Applying Avastin's lessons

With the memory of the 2011 withdrawal of Avastin bevacizumab in breast cancer still fresh in their minds, members of FDA's Oncologic Drugs Advisory Committee recommended against accelerated approval for olaparib from AstraZeneca plc for ovarian cancer. Concerns about the validity and clinical significance of the PFS data led the panel to conclude it could not put the therapy's risks in context.

On June 25, ODAC voted 11-2 against recommending accelerated approval of olaparib as a maintenance therapy for women with platinum-sensitive ovarian cancer...