ODAC to consider two drugs amid FDA skepticism

ODAC is slated to discuss two drugs in September that FDA believes may be associated with a higher risk of death — and that European regulators have recently reviewed and endorsed. The meeting will highlight two topics that FDA’s Oncology Center of Excellence has publicized over the past year, “dangling approvals” and concerns over accumulating toxicities that aren’t detectable in rapid development programs. 

Rounding out the agenda, the Oncologic Drugs Advisory Committee will consider an NDA for poziotinib from Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI), an oral quinazoline-based pan-HER inhibitor that has had a mixed record in Phase II trials for locally advanced or metastatic non-small cell lung cancer (NSCLC)...