CHMP positive decision for Kadcyla, and approval in Japan

20 September 2013

The cancer drug Kadcyla (trastuzumab emtansine) has today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of people with HER2-positive metastatic breast cancer who had previously received Herceptin (trastuzumab) and a taxane chemotherapy.

Kadcyla consists of Swiss drug major Roche’s (ROG: SIX) trastuzumab antibody (Herceptin) and US drug developer ImmunoGen’s (Nasdaq: IMGN), DM1 cytotoxic agent. The DM1 is attached to the antibody using one of ImmunoGen’s linkers. Blockbuster Herceptin, which generated first-half 2013 sales of 3.08 billion Swiss francs ($3.3 billion), could face biosimilar competition as soon as 2016, and it is hoped that Kadcyla will help mitigate in ensuing revenue loss.

Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

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