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Knee Replacement Surgery Procedure

What is a knee replacement surgery?

Knee replacement, also called knee arthroplasty or total knee replacement, is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint, along with the kneecap. This surgery may be considered for someone who has severe arthritis or a severe knee injury.

Various types of arthritis may affect the knee joint. Osteoarthritis, a degenerative joint disease that affects mostly middle-aged and older adults, may cause the breakdown of joint cartilage and adjacent bone in the knees. Rheumatoid arthritis, which causes inflammation of the synovial membrane and results in excessive synovial fluid, can lead to pain and stiffness. Traumatic arthritis, arthritis due to injury, may cause damage to the cartilage of the knee.

The goal of knee replacement surgery is to resurface the parts of the knee joint that have been damaged and to relieve knee pain that cannot be controlled by other treatments.

Anatomy of the knee

Joints are the areas where 2 or more bones meet. Most joints are mobile, allowing the bones to move. Basically, the knee is 2 long leg bones held together by muscles, ligaments, and tendons. Each bone end is covered with a layer of cartilage that absorbs shock and protects the knee.

There are 2 groups of muscles involved in the knee, including the quadriceps muscles (located on the front of the thighs), which straighten the legs, and the hamstring muscles (located on the back of the thighs), which bend the leg at the knee.

Tendons are tough cords of connective tissue that connect muscles to bones. Ligaments are elastic bands of tissue that connect bone to bone. Some ligaments of the knee provide stability and protection of the joints, while other ligaments limit forward and backward movement of the tibia (shin bone).

The knee consists of the following:

Tibia. This is the shin bone or larger bone of the lower leg.

Femur. This is the thighbone or upper leg bone.

Patella. This is the kneecap.

Cartilage. A type of tissue that covers the surface of a bone at a joint. Cartilage helps reduce the friction of movement within a joint.

Synovial membrane. A tissue that lines the joint and seals it into a joint capsule. The synovial membrane secretes synovial fluid (a clear, sticky fluid) around the joint to lubricate it.

Ligament. A type of tough, elastic connective tissue that surrounds the joint to give support and limits the joint's movement.

Tendon. A type of tough connective tissue that connects muscles to bones and helps to control movement of the joint.

Meniscus. A curved part of cartilage in the knees and other joints that acts as a shock absorber, increases contact area, and deepens the knee joint.

Reasons for the procedure

Knee replacement surgery is a treatment for pain and disability in the knee. The most common condition that results in the need for knee replacement surgery is osteoarthritis.

Osteoarthritis is characterized by the breakdown of joint cartilage. Damage to the cartilage and bones limits movement and may cause pain. People with severe degenerative joint disease may be unable to do normal activities that involve bending at the knee, such as walking or climbing stairs, because they are painful. The knee may swell or "give-way" because the joint is not stable.

Other forms of arthritis, such as rheumatoid arthritis and arthritis that results from a knee injury, may also lead to degeneration of the knee joint. In addition, fractures, torn cartilage, and/or torn ligaments may lead to irreversible damage to the knee joint.

If medical treatments are not satisfactory, knee replacement surgery may be an effective treatment. Some medical treatments for degenerative joint disease may include, but are not limited to, the following:

Anti-inflammatory medications

Glucosamine and chondroitin sulfate

Pain medications

Limiting painful activities

Assistive devices for walking (such as a cane)

Physical therapy

Cortisone injections into the knee joint

Viscosupplementation injections (to add lubrication into the joint to make joint movement less painful)

Weight loss (for obese persons)

There may be other reasons for your doctor to recommend a knee replacement surgery.

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What to know about leukemia

Leukemia is a cancer of the blood or bone marrow, which produces blood cells. Leukemia occurs due to a problem with blood cell production. It usually affects the leukocytes, or white blood cells.

Leukemia more often affects people aged over 55 yearsTrusted Source, but it is also the most common cancer in those aged under 15 years.

The National Cancer Institute estimates that 60,650 peopleTrusted Source in the United States will receive a diagnosis of leukemia in 2022. It also predicts that leukemia will cause 24,000 deaths in the same year.

There are different types of leukemia, and the outlook depends on the type. Acute leukemia develops quickly and worsens rapidly, but chronic leukemia gets worse over time.

In this article, we provide an overview of leukemia, causes, treatment, type, and symptoms.

Leukemia developsTrusted Source when damage occurs to the DNA of developing blood cells, mainly white cells. This causes the blood cells to grow and divide uncontrollably.

Usually, healthy blood cells die after a while, and new cells develop in the bone marrow and replace them.

In leukemia, the blood cells grow too quicklyTrusted Source, do not function effectively, and do not die at a natural point in their life cycle. Instead, they build up and occupy more space.

As the bone marrow produces more cancer cells, they begin to overcrowd the blood, preventing the healthy white blood cells from growing and functioning normally. This also affects the platelets and red blood cells.

Eventually, the cancerous cells outnumber healthy cells in the blood.

Find out more about the role of heredity and other causes of leukemia here.

Risk factors

Experts often do not know why leukemia happens, but environmental and genetic factors likely play a roleTrusted Source.

While genetic features may not cause leukemia, they may make it more likely to appear in certain conditions, for example, after exposure to some chemicals or infections.

Risk factors will depend on the type. Some risk factors are avoidable, but others are not.

Scientists have found links between leukemia and various factors, although more research is needed to confirm most of them.

They includeTrusted Source:

a history of certain infections, such as the Epstein-Barr virus

exposure to ionizing radiation, for example, during radiation therapy for a previous cancer, background radiation, or being near a site where people were testing nuclear weapons

having a high or low birth weight

being male, as rates are higher among males

exposure to pesticides and air pollution

having parents who smoke tobacco

having a cesarean delivery before labor started

having a genetic condition such asTrusted Source Down syndrome or Klinefelter syndrome

exposure to benzene

a previous history of chemotherapy

having already had one type of blood cancer

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Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss

What is semaglutide?

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.

There are currently three FDA-approved semaglutide products:

Ozempic injection and Rybelsus tablets are approved to lower blood sugar levels in adults with type 2 diabetes mellitus, in addition to diet and exercise. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease.

Wegovy injection is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight), who also have weight-related medical problems, to lose weight and keep the weight off, in addition to diet and exercise.

All three medications are only available with a prescription, and there are no approved generic versions.

Can semaglutide be compounded?

When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.

Are there concerns with compounded semaglutide?

FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.

Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.

On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products. On Oct. 10, 2023, FDA sent additional letters to the National Association of Boards of Pharmacy and the Federation of State Medical Boards expressing similar concerns. The letters also explain the conditions under which compounded semaglutide products may be permissible under the law, and note that compounded drugs are not FDA-approved or evaluated for safety and effectiveness.

What should patients know about compounded semaglutide drugs?

Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.

Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.

What should health care professionals know?

Health care professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.

Has FDA found illegally marketed semaglutide online?

Yes. FDA vigilantly monitors the internet for fraudulent or unapproved products and has issued warning letters to stop the distribution of illegally marketed semaglutide. These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients.

Has FDA found counterfeit Ozempic in the U.S.?

FDA is aware and is investigating reports of counterfeit Ozempic being marketed in the U.S. The agency investigates any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response, and remains vigilant in protecting the U.S. drug supply from these threats.

How should patients protect themselves?

While we understand certain drugs are in short supply and patients are having difficulty obtaining their medication, FDA urges patients to obtain prescription drugs only from state-licensed pharmacies that are located in the U.S., where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. FDA’s BeSafeRx campaign helps consumers learn about how to safely buy prescription medicines online. FDA recommends patients to talk to their doctor if they have questions about their medicines.

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What Are My Options for Type 2 Diabetes Medications?

There are different types, or classes, of medications that work in different ways to lower blood glucose (also known as blood sugar) levels. Some options are taken by mouth and others are injected. Some of the commonly used classes of non-insulin medications include:

Metformin

Dipeptidyl peptidase 4 (DPP-4) inhibitors

Glucagon-like peptide 1 (GLP-1) and dual GLP-1/gastric inhibitory peptide (GIP) receptor agonists

Sodium-glucose cotransporter 2 (SGLT2) inhibitors

Sulfonylureas

Thiazolidinediones (TZDs)

Metformin

Metformin (Glucophage) is classified as a biguanide medication and is the only available medication in this class. Metformin lowers blood glucose levels primarily by decreasing the amount of glucose produced by the liver. Metformin also helps lower blood glucose levels by making muscle tissue more sensitive to insulin so blood glucose can be used for energy.

It is usually taken two times a day. A side effect of metformin may be diarrhea, but this is improved when the drug is taken with food.

DPP-4 Inhibitors

DPP-4 inhibitors help improve A1C (a measure of average blood glucose levels over two to three months) without causing hypoglycemia (low blood glucose). They work by preventing the breakdown of naturally occurring hormones in the body, GLP-1 and GIP. These hormones reduce blood glucose levels in the body, but they are broken down very quickly so it does not work well when injected as a drug itself.

By interfering in the process that breaks down GLP-1 and GIP, DPP-4 inhibitors allow these hormones to remain active in the body longer, lowering blood glucose levels only when they are elevated. DPP-4 inhibitors do not cause weight gain and are usually very well tolerated.

There are four DPP-4 inhibitors currently on the market in the U.S.:

Alogliptin (Nesina)

Linagliptin (Tradjenta)

Saxagliptin (Onglyza)

Sitagliptin (Januvia)

GLP-1 and Dual GLP-1/GIP Receptor Agonists

As noted in the description for DPP-4 inhibitors, GLP-1 and GIP are natural hormones in the body that help maintain glucose levels. Use of GLP-1 and dual GLP-1/GIP receptor agonists is another strategy to help use these hormones to improve blood glucose management in people with type 2 diabetes.

These medications have similar effects to the GLP-1 and GIP produced in the body but are resistant to being broken down by the DPP-4 enzyme. These medications can result in large benefits on lowering blood glucose and body weight. Some agents in this class have also been shown to prevent heart disease. Most of these medications are injected, with the exception of one that is taken by mouth once daily, called semaglutide (Rybelsus).

Injectable GLP-1 receptor agonists currently on the market include:

Dulaglutide (Trulicity)

Exenatide (Byetta)

Exenatide extended-release (Bydureon)

Liraglutide (Victoza)

Lixisenatide (Adlyxin)

Injectable semaglutide (Ozempic)

One dual GLP-1/GIP receptor agonist is currently on the market called tirzepatide (Mounjaro). How often you need to inject these medications varies from twice daily to once weekly, depending on the medication. The most common side effect with these medications is nausea and vomiting, which is more common when starting or increasing the dose.

SGLT2 Inhibitors

Glucose in the bloodstream passes through the kidneys where it can either be excreted in the urine or reabsorbed back into the blood. Sodium-glucose cotransporter 2 (SGLT2) works in the kidney to reabsorb glucose. A new class of medication, SGLT2 inhibitors, block this action, causing excess glucose to be eliminated in the urine.

By increasing the amount of glucose excreted in the urine, people can see improved blood glucose, some weight loss, and small decreases in blood pressure. Bexagliflozin (Brenzavvy), canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) are SGLT2 inhibitors that have been approved by the Food and Drug Administration (FDA) to treat type 2 diabetes. SGLT2 inhibitors are also known to help improve outcomes in people with heart disease, kidney disease, and heart failure.

For this reason, these medications are often used in people with type 2 diabetes who also have heart or kidney problems. Because they increase glucose levels in the urine, the most common side effects include genital yeast infections.

Sulfonylureas

Sulfonylureas have been in use since the 1950s and they stimulate beta cells in the pancreas to release more insulin. There are three main sulfonylurea drugs used today, glimepiride (Amaryl), glipizide (Glucotrol and Glucotrol XL), and glyburide (Micronase, Glynase, and Diabeta). These drugs are generally taken one to two times a day before meals.

All sulfonylurea drugs have similar effects on blood glucose levels, but they differ in side effects, how often they are taken, and interactions with other drugs. The most common side effects with sulfonylureas are low blood glucose and weight gain.

TZDs

Rosiglitazone (Avandia) and pioglitazone (Actos) are in a group of drugs called thiazolidinediones. These drugs help insulin work better in the muscle and fat and reduce glucose production in the liver.

A benefit of TZDs is that they lower blood glucose without having a high risk for causing low blood glucose. Both drugs in this class can increase the risk for heart failure in some individuals and can also cause fluid retention (edema) in the legs and feet.

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A new kind of diabetes medication approved by the FDA: is there hope for obesity?

Globally, the percentage of people suffering from obesity and type 2 diabetes is constantly increasing. Several epidemiological studies have proven the tight association between diabetes and obesity; it is estimated that more than 80% of type 2 diabetes patients are overweight or obese. Obese individuals with diabetes must be managed with large and persistent weight reduction1. The American Diabetes Association recommends an A1C goal of less than 7%. According to research by the Diabetes Prevention Program, every kilogram lost is associated with a 16% decrease in the development of type 2 diabetes. Moderate weight loss has been associated with decreased insulin resistance, alleviated diabetic complications, reduced cardiovascular disease risk factors, and better glycemic parameters. However, many people with type 2 diabetes find it challenging to reach their blood sugar goals through diet and exercise alone2.

On May 13, 2022, the US Food and Drug Administration (FDA) approved a unique, first-in-class medication for the treatment of type 2 diabetes, known as tirzepatide (Mounjaro). It is administered as a once-weekly injection under the skin and has a dual impact, decreasing blood sugar and promoting weight reduction more effectively than the existing treatments for this illness3. Tirzepatide is a dual incretin agonist. Following a meal, the gut releases hormones called incretins, notably glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Incretins stimulate the pancreas to release the glucose-lowering hormone insulin and block the hormone glucagon, which would cause the liver to release stored glucose, hence raising blood glucose levels. Additionally, incretins postpone stomach emptying, which delays the release of glucose into the bloodstream and encourages satiety.

Type 2 diabetes patients do not respond, as intensely, to incretin hormones as normal people would. Tirzepatide compensates for this deficiency by activating the GLP-1 and GIP receptors in the body. Both hormones are rapidly released after consumption and appear to be controlled by the nervous system. They stimulate insulin synthesis in pancreatic cells in a glucose-dependent way. Furthermore, GLP-1 inhibits pancreatic glucagon release and has extrapancreatic effects such as direct suppressive action on appetite centers and a delay in stomach emptying, boosting the sense of fullness4. Tirzepatide engages with the GIP receptor more than the GLP-1 receptor, indicating an unbalanced mode of action. Pharmacological investigations suggest that tirzepatide resembles the activities of natural GIP at the GIP receptor but favors cAMP production over arrestin recruitment at the GLP-1 receptor, which coincides with a reduced capacity to induce GLP-1 receptor internalization compared to GLP-1. Experiments in primary islets show that arrestin1 reduces the insulin response to GLP-1 but not to GIP or tirzepatide, implying that tirzepatide’s biased agonism increases insulin production5.

In five clinical studies, three distinct dosages of tirzepatide (5, 10, and 15 mg) were studied as either stand-alone treatments or as add-ons to existing diabetic medications. Tirzepatide’s effectiveness was compared with that of a placebo, a GLP-1 receptor agonist (semaglutide), and two long-acting insulin analogs. When used as a stand-alone therapy, patients randomized to receive the recommended dose of tirzepatide (15 mg) had their hemoglobin A1c level lowered by 1.6% more than placebo, and 1.5% more than placebo, when used in combination with long-acting insulin. In trials comparing tirzepatide with other diabetic drugs, individuals who got the highest recommended dose of tirzepatide had a 0.5% lower HbA1c than semaglutide, a 0.9% lower HbA1c than insulin degludec, and a 1.0% lower HbA1c than insulin glargine. Obesity was prevalent among participants, with an average BMI of 32–34 kg/height in m2 reported at enrollment. The average weight reduction with tirzepatide was 15 pounds greater than placebo when neither was taken with insulin and 23 pounds greater than placebo when both were used with insulin among participants, randomized to the highest indicated dosage. With the highest prescribed dose of tirzepatide, the average weight reduction was 12 pounds greater than with semaglutide, 29 pounds greater than with insulin degludec, and 27 pounds greater than with insulin glargine. Patients who received insulin without tirzepatide gained weight during the trial6.

Moreover, ascertaining the weight loss, another recent double-blinded randomized controlled trial was published in NEJM where all patients intervened for Tirzepatide showed a greater tendency to lose weight when compared with patients taking placebo7. However, there were complications with the methodology of the trial; participants involved were more committed to losing weight, thus requiring a change in lifestyle; changes in cardiometabolic variables were not inspected due to insufficient time span; and, lastly, there was a lack of diversity; the study involved fewer patients who were suffering from obesity and an obesity-induced disease simultaneously. The above-stated reasons contributed to imprecise results7.

The most prevalent adverse effects of tirzepatide reported by trial participants were nausea, diarrhea, vomiting, and constipation. Severe hypoglycemia happened on rare occasions. Researchers are still studying tirzepatide’s long-term safety and possible impacts on cardiovascular events, including heart attack, stroke, and death8. In rats, tirzepatide produces thyroid C-cell tumors, but it is uncertain if tirzepatide produces similar cancers in humans, such as medullary thyroid carcinoma. Additionally, tirzepatide should not be used in people who have a personal or familial history of medullary thyroid cancer or who have multiple endocrine neoplasia type 2, and it has not been examined in individuals with a history of pancreatic inflammation (pancreatitis). Similarly, it is also not recommended for type 1 diabetic patients9.

The early clinical development of a multifaceted single pharmacological drug, such as tirzepatide, with the capacity to drastically drop glucose levels, increase insulin sensitivity, reduce weight, and improve dyslipidemia is critical. As a result, tirzepatide appears to be both a novel antidiabetic drug and an antiobesity treatment. It is too early to be unduly optimistic since further research is warranted to evaluate the long-term effects of this drug and adequately validate the possible advantages.

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FDA Roundup: Oncology Drug Alerts

The US Food and Drug Administration (FDA) approved several new treatments for a range of cancers over the summer.

In July, the FDA approved a new indication for Jemperli (dostarlimab) in endometrial cancer. In August, the FDA granted accelerated approval for Talvey (talquetamab) and Elrexfio (elranatamab) to treat multiple myeloma.

Other August approvals include a new indication for Lonsurf (trifluridine and tipiracil) in colorectal cancer, a new indication for Gavreto (pralsetinib) in non-small cell lung cancer, Akeega (niraparib and abiraterone acetate) for prostate cancer, and Hepzato Kit (melphalan for injection/hepatic delivery system) for patients with uveal melanoma and unresectable hepatic metastases.

In early September, the FDA approved Aphexda (motixafortide) for use in patients with multiple myeloma undergoing autologous transplant. In mid-September, the FDA approved updated labeling for Temodar (temozolomide) to include patients with anaplastic astrocytoma.

New Drug Approvals

Jemperli (Dostarlimab-gxly)1

On July 31, 2023, the FDA approved Jemperli in combination with carboplatin and paclitaxel, followed by single-agent Jemperli, for adults with primary advanced or recurrent endometrial cancer that is mismatch repair-deficient (dMMR) or microsatellite instability high.

Jemperli was previously approved as monotherapy for adults with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or after treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

Jemperli also has accelerated approval as monotherapy for adults with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or after prior treatment and who have no satisfactory alternative treatment options.

Lonsurf (Trifluridine and Tipiracil)2

On August 2, 2023, the FDA approved Lonsurf in combination with bevacizumab for adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy.

The FDA previously approved Lonsurf monotherapy for the aforementioned patient population. Lonsurf is also approved to treat metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 lines of chemotherapy including a fluoropyrimidine, a platinum, either a taxane or irinotecan, and, if appropriate, HER2-targeted therapy.

Talvey (Talquetamab-tgvs)

On August 9, 2023, the FDA granted accelerated approval for Talvey to treat adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Gavreto (Pralsetinib)4

On August 9, 2023, the FDA granted full approval to Gavreto for adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

Gavreto was previously granted accelerated approval for the aforementioned indication and to treat adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and whose disease is refractory to radioactive iodine.

Akeega (Niraparib and Abiraterone Acetate)5

On August 11, 2023, the FDA approved Akeega in combination with prednisone to treat adults with deleterious or suspected deleterious BRCA-mutated, metastatic castration-resistant prostate cancer, as determined by an FDA-approved test.

Elrexfio (Elranatamab-bcmm)6

On August 14, 2023, the FDA granted accelerated approval to Elrexfio for the treatment of adults with relapsed or refractory multiple myeloma who previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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Recent FDA-Approved Cancer Treatments and Therapies

Tisagenlecleucel (Kymriah) is the first personalized gene therapy in the United States for:

Children and adults with relapsed/refractory B-cell acute lymphoblastic leukemia (2017.)

Adults with relapsed and refractory aggressive B-cell lymphoma (2018.)

Adults with relapsed/refractory follicular lymphoma (2022.)

Tocilizumab (Actemra) treats side effects from cancer immunotherapy (2017.)

Olapirib (Lynparza) targets BRCA-mutated refractory ovarian cancer and metastatic breast cancer (2018) and early-stage breast cancer with BRCA1/2 mutations (2022.)

Iobenguane I 131 (Azedra) is the first and only treatment option for adults and children with advanced and inoperable pheochromocytomas and paragangliomas (2018.)

Gilteritinib (Xospata) is the first drug of its kind for relapsed or refractory FLT3-mutated acute myeloid leukemia (2018.)

Transoral Robotic Surgery (TORS) was approved as a technology for operating on head and neck cancers (2019.)

Selinexor (Xpovio) is the first treatment of its kind for relapsed/refractory multiple myeloma (2019.)

Entrectinib (Rozlytrek) targets NTRK-mutated cancers in children and adults and ROS1-mutated non-small-cell lung cancers in adults (2020.)

Fluoroestradiol F 18 (Cerianna) enables visual detection of recurrent breast cancer by PET scan (2020.)

Belantamab mafodotin-blmf (Blenrep) is the first antibody – drug conjugate that selectively targets and kills myeloma cells to treat relapsed/refractory multiple myeloma (2020.)

Crizotinib (Xalkori) treats relapsed/refractory ALK-mutated systemic anaplastic large-cell lymphoma as well as inflammatory ALK-mutated myofibroblastic tumors in children and young adults (2021-22.)

Belzutifan (Welirig) is the first therapy of its kind for treating von Hippel – Lindau disease-associated tumors, such as renal cell carcinoma, central nervous system hemangioblastomas and pancreatic neuroendocrine tumors (2021.)

Cabozantinib (Cabometyx) treats refractory differentiated thyroid cancer in children and adults (2021.)

Pafolacianine (Cytalux) is the first FDA-approved substance to illuminate ovarian cancer (2021) and lung cancer (2022) lesions during surgery.

Teclistamab-cqvy (Tecvayli) is the first bispecific T cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (2022.)

Mosunetuzumab-axgb (Lunsumio) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy (2022.)

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FDA approves capivasertib with fulvestrant for breast cancer

On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

The full prescribing information for Truqap will be posted here.

Efficacy was evaluated in CAPItello-291 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial in 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 patients had tumors with PIK3CA/AKT1/PTEN-alterations. All patients were required to have progression on aromatase inhibitor-based treatment. Patients could have received up to two prior lines of endocrine therapy and up to 1 line of chemotherapy for locally advanced or metastatic disease.

Patients were randomized (1:1) to either capivasertib 400 mg or placebo administered orally twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Both investigational and control arm patients received Fulvestrant 500 mg intramuscularly on cycle 1 days 1 and 15, and then every 28 days thereafter. Patients received therapy until disease progression or unacceptable toxicity.

The major efficacy outcome measure was investigator-assessed progression-free survival (PFS) in the overall population and in the population of patients whose tumors had PIK3CA/AKT1/PTEN-alterations evaluated according to RECIST, version 1.1. A statistically significant difference in PFS was observed in the overall population and in the population of patients whose tumors have PIK3CA/AKT1/PTEN-alteration(s).

In the 289 patients with PIK3CA/AKT1/PTEN-altered tumors, the median PFS was 7.3 months (95% CI: 5.5, 9.0) in the capivasertib-fulvestrant group and 3.1 months (95% CI: 2.0, 3.7) in the placebo-fulvestrant group (Hazard Ratio [HR] 0.50 [95% CI: 0.38, 0.65] p-value< 0.0001).

An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN-alteration showed a HR of 0.79 (95% CI: 0.61, 1.02), indicating that the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN-alteration.

The most common adverse reactions (reported in ≥20% of patients), including laboratory abnormities were diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting and stomatitis.

The recommended capivasertib dose is 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, Israel’s Ministry of Health (IMoH), Singapore’s Health Sciences Authority (HSA), Switzerland's Swissmedic, and United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies.

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FDA Oncology Approval

The world of oncology continues to advance at a rapid pace, as multiple new drugs have been approved for various cancer types — both solid and hematologic malignancies — over the last few months. There are also new therapies in the pipeline, too, as ongoing clinical trials are leading to New Drug Applications, Priority Reviews and more from the Food and Drug Administration (FDA).

In March, the FDA approved Zynyz (retifanlimab-dlwr) for patients with metastatic or locally recurrent Merkel cell carcinoma — a rare type of skin cancer. The approval, which was based off findings from the PODIUM-201 trial, marks the first PD-1 inhibitor (a type of drug that blocks the PD-1 protein on cancer cells, thereby preventing them from hiding from the immune system) to be approved for this patient population.

Lynparza plus abiraterone for BRCA-mutant prostate cancer.

The FDA approved Lynparza (Olaparib) plus abiraterone and prednisone for patients with deleterious or suspected deleterious BRCA-mutant castration-resistant prostate cancer, based on findings from the PROpel clinical trial, which showed that adding Lynparza to abiraterone significantly improved the time patients lived before their disease got worse (an endpoint known as progression-free survival) compared with placebo plus abiraterone.

Polivy combination for diffuse large B-cell lymphoma.

Polivy (polatuzumabvedotin-piiq) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone was approved in April for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), ending a nearly 20-year period where no new options were approved for this patient population. The approval was based on findings from the POLARIX trial, which showed that the newly approved regimen led to a 27% reduction in the risk of disease progression or death compared with the current standard of care.

Padcev plus Keytruda for advanced bladder cancer.

Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) was granted an accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer) who are not eligible to receive cisplatin-based chemotherapy, a group that, according to one expert, is comprised of approximately 8,000 to 9,000 patients in the United States. Two clinical trials — EV-103 and KEYNOTE-869 — led to the regimen’s approval, after they showed that the majority of patients given Padcev plus Keytruda experienced a response, while 12% had their disease completely disappear.

Epkinly for relapsed/refractory diffuse large B-cell lymphoma.

In May, the FDA approved another regimen — Epkinly (epcoritamab-bysp) — for DLBCL, this time for patients with relapsed or refractory disease or for those with disease that is the result of indolent lymphoma and high-grade B-cell lymphoma that has been treated with two or more lines of therapy. The FDA made the approval decision based on findings from the EPCORE NHL-1 trial, which showed that 61% of patients responded to the treatment (meaning that their cancer shrank or disappeared), with 38% of patients experiencing a complete response, meaning that there were no signs of cancer after treatment.

New therapies are constantly being investigated in the cancer space.

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Landmark Melanoma Vaccine Could Be Available in Just 2 Years :

Globally there were an estimated 325,000 new melanoma cases and 57 ,000 deaths from the disease in 2020.

"We think that in some countries the product could be launched under accelerated approval by 2025," he said in an interview.

#vaccine #moderna

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FDA Approves First Stimulation Therapy Device for Episodic Cluster Headache:

The US Food and Drug Administration (FDA) has approved a noninvasive vagus nerve stimulation device for the treatment of pain from episodic cluster headache in adults. The portable device, called gammaCore, lets patients self-administer mild electrical stimulation to the vagus nerve whenever they need relief from the debilitating symptoms of cluster headache — a condition that affects about 350,000 individuals in the United States.

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New York’s Trans Fat Ban Reduced Heart attacks and Strokes:

Trans fat bans are actually helping New York residents stay healthy, new research suggests. Hospitals in New York counties that banned the heart-clogging oils saw a 6.2 percent drop in heart attacks and strokes starting three years later, compared to areas without restrictions on trans fats, says an article published in JAMA Cardiology. That means there were 43 fewer heart attacks and strokes per 100,000 people.

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$1 Drug Could Save Thousands Of Mothers After Childbirth:

Every year about 100,000 women around the world die of blood loss soon after a baby is born. It’s the biggest cause of maternal death worldwide. Back in the 1960s, a female doctor in Japan created a powerful drug (tranexamic acid) to help mothers who hemorrhage after childbirth. The medicine is inexpensive to make. It’s safe to use. And it stops bleeding quickly by helping keep naturally forming blood clots intact. Tranexamic acid has gone largely unused in maternity wards for decades. However, recently, a massive international trial showed that hat tranexamic acid decreased the risk of death from blood loss associated with childbirth by about a third. In the study, women who were diagnosed with heavy bleeding, or postpartum hemorrhage, after a vaginal birth or cesarean section received either the drug or a placebo. About 1.2 percent of women who got tranexamic acid within three hours of a hemorrhage died, compared with 1.7 percent of the women who got the placebo.

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FDA approves first drug to treat Tardive dyskinesia:

The U.S. Food and Drug Administration approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition. Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing.

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FDA approves New Combination Treatment for Acute Myeloid Leukemia

The U.S. Food and Drug Administration approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. Rydapt is a kinase inhibitor that works by blocking several enzymes that promote cell growth. If the FLT3 mutation is detected in blood or bone marrow samples using the LeukoStrat CDx FLT3 Mutation Assay, the patient may be eligible for treatment with Rydapt in combination with chemotherapy.

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How to identify lung signs on x-rays

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Alzheimer’s Disease

Alzheimer’s is a type of dementia that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks.