Perjeta pertuzumab regulatory update

The European Commission approved an MAA from Roche for Perjeta pertuzumab to treat previously untreated HER2-positive metastatic breast cancer. The product is approved in combination with Herceptin trastuzumab and docetaxel to treat adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti- HER2 therapy or chemotherapy. Perjeta is a mAb HER dimerization inhibitor that prevents HER2 from binding to other HER receptors ( HER1/EGF, HER3 and HER4). Roche's Genentech unit markets Herceptin in the U.S., while Roche markets it elsewhere.

Last June, FDA approved a BLA from Roche's Genentech unit for Perjeta to treat previously untreated HER2-positive metastatic breast cancer in combination with Herceptin and docetaxel. However, the agency only approved Perjeta that contains drug substance produced during 2010 that was unaffected by recent manufacturing problems, and Genentech is required to submit sBLAs for drug substance produced after 2010 (see BioCentury, June 18, 2012). Roche said the EU approval does not require a similar "campaign by campaign" approval as FDA requested. ...