FDA Approves Roche's Kadcyla

Roche ( RHHBY ) recently announced that the US Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of patients suffering from HER2-positive metastatic breast cancer (mBC).

These patients were previously treated with Herceptin (trastuzumab) and taxane chemotherapy.

The approval was based on positive results from a phase III study (EMILIA: N=991). The study compared Kadcyla (trastuzumab emtansine) to GlaxoSmithKline's ( GSK - Analyst Report ) Tykerb (lapatinib) along with Roche’s Xeloda (capecitabine) in these patients.

Roche has partnered with ImmunoGen, Inc. ( IMGN - Snapshot Report ) for Kadcyla. We note that Roche filed a New Drug Application (NDA) for Kadcyla in Jan 2013 after being granted a priority review in the US in Nov 2012.

In Aug 2012, Roche had filed a Biologics License Application (BLA) for Kadcyla for the treatment of HER2-positive unresectable locally advanced or metastatic breast cancer patients.

Roche also submitted a marketing authorization application for Kadcyla to the European Medicines Agency (EMA) for use in treatment-experienced HER2-positive metastatic breast cancer patients. The application is currently under review.

Meanwhile, in Dec 2012, the European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for Perjeta (pertuzumab) plus Herceptin (trastuzumab) and docetaxel to treat patients with HER2-positive metastatic or locally recurrent unresectable breast cancer (mBC).

The approval of Kadcyla will strengthen Roche's HER2 franchise. Roche expects Perjeta, Kadcyla and Actemra to positively impact results in 2013.

Roche currently carries a Zacks Rank #4 (Sell). Another large-cap pharma stock, Bayer ( BAYRY - Analyst Report ) , currently looks attractive with a Zacks Rank #2 (Buy).