CHMP backs Perjeta

EMA's CHMP issued several positive opinions on Friday, including recommending approval of Perjeta pertuzumab from Roche (SIX:ROG; OTCQX:RHHBY) for breast cancer. The pharma is seeking approval for the drug to treat HER2-positive, metastatic or locally recurrent unresectable breast cancer in combination with Herceptin trastuzumab and docetaxel in patients who have not received previous anti- HER2 therapy or chemotherapy. In June, FDA approved the mAb HER dimerization inhibitor that prevents HER2 from binding to other HER receptors ( HER1/EGF, HER3 and HER4). However, the agency only approved Perjeta that contains drug substance produced during 2010 that was unaffected by recent manufacturing problems (see BioCentury, June 18). ...