FDA to discuss Perjeta for neoadjuvant breast cancer

FDA's Oncologic Drugs Advisory Committee (ODAC) will meet on Sept. 12 to discuss an sBLA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Perjeta pertuzumab as neoadjuvant treatment in HER2-positive early-stage breast cancer patients. The drug is under Priority Review with an Oct. 31 PDUFA date. There are currently no FDA-approved neoadjuvant treatments for breast cancer (see BioCentury Extra, July 2). ...