Hearing Committee Unanimously Favors Removing Avastin’s MBC Indication

An FDA appeals hearing panel emphatically recommended nixing the metastatic breast cancer (MBC) indication for Genentech’s Avastin, pointing to its significant toxicities and failure to show clinical benefit. “We tried to slice this pie in a lot of ways to try to find some benefit for this drug,” Mikkael Sekeres, Cleveland Clinic Taussig Cancer Institute, said Wednesday during a two-day appeals hearing on the indication.
Drug Industry Daily