FDA panel backs early use of Perjeta

FDA's Oncologic Drugs Advisory Committee voted 13-0, with one abstention, that Perjeta pertuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) has a favorable benefit-risk profile for neoadjuvant breast cancer. Genentech is seeking accelerated approval of Perjeta in combination with Herceptin trastuzumab and docetaxel for HER2-positive, locally advanced, inflammatory or early-stage breast cancer prior to surgery. The sBLA for Perjeta is under Priority Review, with an Oct. 31 PDUFA date.

If FDA follows the panel's advice, Perjeta would be the first drug approved for pre-surgical breast cancer. In June 2012, FDA issued draft guidance on the use of pathologic complete response (pCR) as a surrogate endpoint for accelerated approval of treatments for neoadjuvant breast cancer. FDA expects to publish final guidance in the fall. ...