Roche’s Kadcyla approved in the EU for advanced HER2-positive breast cancer

Swiss drug major Roche (ROG: SIX) says that Kadcyla (ado-trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer.

Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab) and a taxane, separately or in combination. The indication also stipulates that those treated should either have received prior therapy for locally advanced or metastatic disease, or have had disease recurrence during or within six months of completing adjuvant therapy.

Earlier this year, the US Food and Drug Administration approved Kadcyla as new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, developed by Genentech, the US biotech subsidiary of Swiss drug major Roche (The Pharma Letter February 25). Roche licenses technology for Kadcyla under an agreement with ImmunoGen.