FDA Actions

FDA Actions

The FDA is removing the breast cancer indication for bevacizumab (Avastin-Genentech). The somewhat unusual move was made after an FDA advisory panel suggested last summer that the drug did not provide a survival benefit for patients with breast cancer and at the same time caused serious side effects. The drug is still approved for treating cancer of the brain, colon, kidney, and lung.

The FDA advisory panel is recommending approval for the first new diet pill in a decade. Orexigen Therapeutics' Contrave^® is a combination of the antidepressant bupropion and the opioid antagonist naltrexone. The drug was recommended for approval by a vote of 13-7, with some committee members voicing concern about potential side effects of the drug and recommending close post-marketing follow-up and studies to assess the risk of major cardiac events. The recommendation to approve the drug was based on studies that show an average weight loss 4.2% greater than placebo.

The FDA has approved denosumab for the prevention of skeletal related events (fracture and bone pain) in patients with bone metastases from solid tumors. The drug, which is given as a once monthly injection, was approved after a 6-month priority review. Denosumab is a monoclonal antibody to RANKL, a protein essential for the formation, function, and survival of osteoclasts. Denosumab in a lower-dose formulation was recently approved for the treatment of osteoporosis under the trade name Prolia. Amgen Inc. will market the drug for this new indication under the trade name Xgeva. It is expected to compete strongly with Novartis Pharmaceutical's zoledronic acid (Zometa^®), which is approved for the same indication.