FDAnews Drug Daily Bulletin

Roche Gets EU Approval Nod for Kadcyla

Nov. 21, 2013

The European Commission has approved Roche’s Kadcyla to treat patients with HER2-positive locally advanced or metastatic breast cancer previously treated with Herceptin and/or a taxane.

The approval nod is based on data from the Phase III EMILIA study, which showed Kadcyla (trastuzumab emtansine) significantly extended overall patient survival when compared with the combination of GlaxoSmithKline’s Tykerb (lapatinib) and Roche’s Xeloda (capecitabine).

Patients taking Kadcyla also reported fewer severe side effects associated with chemotherapy, the Swiss pharma giant said Wednesday.

Kadcyla, approved by the FDA in February, shares the active ingredient trastuzumab with Roche’s blockbuster Herceptin and is one of only a handful of new breast cancer drugs expected to hit what could be a $10.8 billion market by 2018, industry experts say. — Lena Freund

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