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Weekly Drug News Round-Up: November 11, 2015

Cotellic Approved for Combo Treatment in Advanced Melanoma

Cotellic works by blocking the activity of an enzyme known as MEK, which is part of a larger signaling pathway Read More...

Melanoma is the most aggressive form of skin cancer in the U.S. This week, the FDA approved Cotellic (cobimetinib), an oral kinase inhibitor used in combination with vemurafenib (Zelboraf) for the treatment of advanced melanoma with a BRAF V600E or V600K mutation. In studies, patients taking Cotellic plus vemurafenib had roughly a 12.3 month delay in worsening of their melanoma compared to 7.2 months for those taking vemurafenib only. In addition, 65% of patients in the cobimetinib plus vemurafenib group were alive after 17 months of starting treatment; 50% were alive in the vemurafenib only group.

Genvoya Tablet Cleared As Complete HIV-1 Infection Regimen

Genvoya contains a new form of tenofovir that has not been previously approved Read More...

The FDA has approved Gilead’s Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for HIV-1 infection in patients 12 years of age and older. Genvoya can be used in patients weighing at least 35 kilograms (77 pounds) who are treatment-naïve and in HIV-infected adults whose HIV-1 virus is currently suppressed. The new form of tenofovir is present more in the infected cell than the bloodstream, and has less kidney toxicity and decreases in bone density than previously approved tenofovir regimens. Genvoya carries a Boxed Warning of a build-up of lactic acid in the blood and severe liver problems.

FDA: Plavix Long-Term Treatment Does Not Change Risk of Death

Clopidogrel is used to prevent blood clots after heart attack, stroke, or with circulation problems Read More...

FDA has determined that the blood thinner clopidogrel (Plavix) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease; or increase the risk of cancer or death due to cancer. Based on the Dual Antiplatelet Therapy (DAPT) trial, concerns surfaced over the increased risk of death and cancer using clopidogrel. FDA reviewed DAPT and other clinical trials to assess the effects of clopidogrel on all-cause death rates, cancer death rates, or cancer as an adverse event. The results indicate that long-term (1 year or longer) therapy with clopidogrel and aspirin do not appear to change the overall risk of death when compared to short-term (6 months or less) use of clopidogrel and aspirin, or aspirin alone.

Antibiotic Class Linked to Risk of Sudden Cardiac Death

Macrolides treat infections such as pneumonia, bronchitis, and some sexually transmitted diseases Read More...

Macrolide antibiotics, such as erythromycin, azithromycin (Zithromax) and clarithromycin (Biaxin), are a widely used drug class. A new study published in the Journal of the American College of Cardiology has found a small, but statistically significant increased risk of sudden cardiac death associated with macrolides; however, a definitive cause-and-effect was not proven. Studies showed that one in every 8,500 patients treated with macrolides could develop a serious heart rhythm problem and one in 30,000 might die. Even though the risk is small, given the large number of patients that use macrolides, the number of events overall may be consequential.

Side Effects Caused Patients to Stop Blood Thinner: Study

Brilinta lowers the risk of stroke or serious heart problems after a heart attack or severe chest pain (angina) Read More...

In a recent study with Brilinta (ticagrelor), researchers found that 19 percent of those taking 90 milligrams (mg) and 16 percent of those taking 60 mg, compared with just 9 percent of those on placebo dropped out due to side effects; a significant finding. Study discontinuation was commonly linked with side effects like shortness of breath and non-serious bleeding. Most people who dropped out did so in the first year. As most side effects were not life-threatening, researchers felt more education is needed to describe the potential side effects of the drug, as well as its importance to prevent further cardiovascular events.