Japan approves Kadcyla, CHMP backs it

EMA's CHMP recommended approval of an MAA from Roche (SIX:ROG; OTCQX:RHHBY) and Japan approved an NDA from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) for Kadcyla ado-trastuzumab emtansine to treat HER2-positive breast cancer. The approval from Japan's Ministry of Health, Labor and Welfare (MHLW) triggered a $5 million milestone payment to ImmunoGen Inc. (NASDAQ:IMGN). European Commission approval of the product would trigger a second $5 million milestone payment.

Kadcyla is under review in the EU to treat HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin trastuzumab and a taxane. FDA approved Kadcyla for the indication in February. In Japan, the product is indicated for inoperable or recurrent HER2-positive breast cancer. ...