FDA nod for new Kadcyla indication

4 May 2019

The US Food and Drug Administration has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment.

Kadcyla, from Swiss pharma giant Roche’s (ROG: SIX) subsidiary Genentech, is already approved to treat patients with metastatic HER2-positive breast cancer who underwent prior treatment with trastuzumab and taxane chemotherapy. It generated sales of 979 million Swiss francs ($970 million) in 2018.

Approved under RTOR program

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