FDA approves Genentech's Perjeta

FDA granted accelerated approval to Perjeta pertuzumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for neoadjuvant breast cancer. The product is indicated in combination with Herceptin trastuzumab and other chemotherapy for HER2-positive, locally advanced, inflammatory or early stage breast cancer prior to surgery. Perjeta is the first drug approved in this setting and the first successful application of pathologic complete response (pCR) as a surrogate endpoint. The approval comes a month prior to its Oct. 31 PDUFA date (see BioCentury, Sept. 16). ...