FDA reviewers back early use of Perjeta

FDA reviewers said Perjeta pertuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) showed a significant improvement in pathologic complete response (pCR) for neoadjuvant breast cancer with an "acceptable safety profile." FDA reviewers did say Genentech should conduct a cardiac safety study of Perjeta in neoadjuvant patients to address an imbalance in cardiac events seen in clinical trials, but the reviewers did not specify whether the trial should be done pre- or post-approval. Perjeta's label already includes a warning of left ventricular dysfunction. The comments came in Herceptin trastuzumab and docetaxel as neoadjuvant treatment in HER2-positive early stage breast cancer patients. The drug is under Priority Review with an Oct. 31 PDUFA date.

Genentech is seeking accelerated approval for Perjeta for pre-surgical breast cancer, a setting for which there are no approved drugs. In June 2012, FDA issued draft guidance on the use of pCR as a surrogate endpoint for accelerated approval of new treatments for neoadjuvant breast cancer. FDA expects to issue final guidance in the fall (see BioCentury, July 23, 2012). ...