FDA Approvals, News & Updates

The FDA approved the newest oral kinase inhibitor axitinib (Inlyta; Pfizer) for the treatment of patients with advanced renal-cell carcinoma that has failed to respond to previous therapy.

The US Food and Drug Admin­istration (FDA) approved vismodegib (Erivedge; Hoffmann–La Roche), a hedgehog pathway inhibitor, for the treatment of basal-cell carcinoma (BCC) in adults with locally advanced disease who are not candidates for surgery or radiotherapy and in those with metastatic disease.

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.