Perjeta gets Priority Review for neoadjuvant breast cancer

FDA accepted and granted Priority Review to 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 PDUFA date is Oct. 31. Perjeta is already approved in the U.S. and EU to treat previously untreated HER2-positive metastatic breast cancer in combination with Herceptin trastuzumab and docetaxel, and in Japan to treat HER2-positive inoperable or recurrent breast cancer.

There are currently no FDA-approved neoadjuvant treatments for breast cancer. Genentech's sBLA follows draft FDA guidance on neoadjuvant therapy for early stage breast cancer that was released last year. FDA said it is working to finalize the guidance (see BioCentury, July 23, 2012). ...