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Weekly Drug News Round-Up: October 25, 2017

Yescarta Gene Therapy Approved for Large B Cell Lymphomas

The second CAR T-cell therapy has been approved, but it’s the first for certain non-Hodgkin (NHL) lymphomas Read More...

Chimeric antigen receptor T cell (CAR T) therapy is a breakthrough, personalized cancer treatment allowing many patients with certain blood cancers -- but limited treatment options -- to achieve remission. The U.S. Food and Drug Administration (FDA) has now cleared Kite Pharma/Gilead’s Yescarta (axicabtagene ciloleucel) for adults with large B-cell lymphoma after failing at least two other kinds of treatment. To develop the CAR T cell treatment, the patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient to attack the cancer. However, side effects, such as cytokine release syndrome (CRS), can be serious or fatal. Go here to learn more about CAR-T cell therapy.

Shingrix Zoster Vaccine Approved for Prevention of Shingles

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox Read More...

The FDA has approved GSK’s Shingrix (zoster vaccine recombinant, adjuvanted), a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults 50 years and older. Shingrix is given as two intramuscular injections, with the second dose given 2 to 6 months after the first. In studies of more than 38,000 people spanning a follow-up period of 4 years, Shingrix was effective against shingles in greater than 90% of all age groups. The incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles was also reduced. The CDC’s Advisory Committee on Immunization Practices (ACIP) also recommends Shingrix vaccine over Zoster Vaccine Live (Zostavax). Those who previously received Zostavax should now also receive Shingrix.

FDA Approves Soliris for Generalized Myasthenia Gravis

Soliris selectively inhibits the terminal complement cascade, targeting a critical underlying cause of the disease Read More...

Myasthenia gravis (MG) is a progressive immune-mediated neuromuscular disorder that leads to muscle weakness in the eyes, head, neck, trunk, limb and respiratory muscles. The FDA has now approved Alexion's Soliris (eculizumab) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. In the REGAIN studies, effectiveness was shown in those who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing.

FDA Clears Once-Weekly Bydureon BCise for Type 2 Diabetes

Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist used to control blood glucose in type 2 diabetes Read More...

A new formulation of Bydureon (exenatide extended-release) injectable, once-weekly suspension was FDA-approved this week. The new formulation, the Bydureon BCise autoinjector device, is a continuous-release microsphere delivery system designed to provide consistent blood levels of exenatide. It is used in type 2 diabetes patients whose blood sugar remains uncontrolled despite being on one or more oral medicines in addition to diet and exercise. Bydureon BCise will be available for patients in the US in the first quarter of 2018. Bydureon Pen will also remain available for patients.

Do Statins Raise the Risk for Type 2 Diabetes? Study

Check with your doctor if you are concerned; do not stop your statin, which could increase heart attack or stroke risk Read More...

In an observational study, researchers have found that statins, medications used commonly to lower risk of heart disease may also elevate the risk for type 2 diabetes. How does this occur? Insulin secretion goes down with statin use, and less insulin would lead to higher blood sugar levels. In those already at risk of type 2 diabetes (overweight, family history, prediabetes), statins appeared to increase the diabetes risk by about 30%. But statins are effective in lowering the risk of heart attack or stroke by about 40% and stopping them could increase that risk, too. Simvastatin (Zocor) and atorvastatin (Lipitor) were the most commonly used statins in the study.