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Weekly Drug News Round-Up: April 27, 2016

Carbometyx Now Approved for Advanced Kidney Cancer

Multikinase inhibitors decrease tumor growth by inhibiting cell kinases implicated in tumor growth and metastatic progression of cancer Read More…

Renal cell carcinoma (RCC) is the most common form of kidney cancer in adults. Cabometyx (cabozantinib) is a oral multikinase inhibitor now approved for the treatment of patients with advanced RCC who have received prior anti­-angiogenic therapy. In the phase 3 METEOR trial and as published in the New England Journal of Medicine, Cabometyx was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus. Common side effects for Cabometyx include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.

Abuse-Deterrent Painkiller Xtampza-ER is FDA-Approved

Collegium plans to launch Xtampza ER in the United States in mid-2016 Read More...

The FDA has approved Collegium Pharmaceuticals’ Xtampza ER (oxycodone) capsules, an extended-release, abuse-deterrent narcotic analgesic for the treatment of chronic pain. A schedule II narcotic, Xtampza ER capsules are given twice daily as long-term opioid treatment for severe pain without adequate alternative treatments.  Xtampza ER capsules prevent dangerous and potent rapid release of the opioid when chewed or crushed, but allows flexible administration of the product by sprinkling the capsule contents on soft foods or into a cup, and then into the mouth or feeding tube.

AstraZeneca’s Bevespi Aerosphere Wins Approval for COPD

AstraZeneca’s new technology allows consistent delivery of multiple medicines from a single inhaler Read More...

Bevespi Aerosphere (formoterol fumarate/glycopyrrolate) is a long-acting, fixed dose beta2-adrenergic agonist (LABA) and anticholinergic combination approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere is used twice a day via a pressurized metered dose inhaler (pMDI). In studies, Bevespi Aerosphere achieved lung function endpoints (significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks) compared to its individual agents and placebo. There were no unexpected safety findings; common side effects included cough.

FDA Evaluates Low-Dose Fluconazole Use in Pregnancy

It is estimated that 10 percent of pregnant women will develop a vaginal yeast infection Read More...

FDA is evaluating the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) at low, single doses (150 mg) for vaginal yeast infections in pregnant women. Current labeling states higher doses of oral fluconazole (400 to 800 mg/day) used in pregnancy for more than a single dose have resulted in birth abnormalities; however, studies do not suggest an increased risk of problems during pregnancy or birth defects when women are exposed to a single 150 mg dose of oral fluconazole. FDA is reviewing the data and will communicate final conclusions and recommendations when the review is complete.

Common Breast Cancer Meds Have No Increased Risk of Fatal Heart Events

Aromatose inhibitors are hormone therapy used to reduce breast cancer recurrence Read More…

A new, large study done by Kaiser Permanente reports that the breast cancer preventive agents known as aromatase inhibitors, such as Femara (letrozole), do not raise the risk of heart attacks and strokes among breast cancer survivors any more than tamoxifen. However, women who took only aromatase inhibitors or used them after tamoxifen treatment had up to a 29 percent higher risk of other heart problems (certain arrhythmias, pericarditis) than those who took only tamoxifen, the research revealed. Previous research has linked tamoxifen, another commonly prescribed breast cancer drug, with an increased risk of stroke.