FDA Approvals, News & Updates

The FDA has revoked its previous accelerated (and conditional) approval for bevacizumab (Avastin, Genentech) for the treatment of metastatic breast cancer (MBC), citing safety concerns that outweigh its benefits in this patient population.

The FDA approved 2 new indications for denosumab (Prolia, Amgen) for treating patients at high risk for therapy-induced bone fracture.

The FDA expedited the approval of brentuximab vedotin (Adcetris, Seattle Genetics) for the treatment of Hodgkin lymphoma, as well as for systemic anaplastic large-cell lymphoma (ALCL), a rare non-Hodgkin lymphoma that may manifest in several parts of the body, including the lymph nodes, skin, bones, soft tissue, lungs, and liver.