Roche receives US approval for breast cancer drug Kadcyla

Pharmaceutical Company Product News

Roche has been granted US regulatory approval for an innovative new personalised medical therapy for patients with HER2-positive metastatic breast cancer.

Kadcyla, also known as trastuzumab emtansine or T-DM1, has been ratified by the US Food and Drug Administration (FDA) as the first antibody-drug conjugate for this patient group, having demonstrated its efficacy in the phase III study Emilia.

The treatment is intended for patients who have received prior treatment with Herceptin and a taxane chemotherapy and is the fourth medicine from Roche to receive FDA approval for advanced cancers within the past two years.

This approval augurs well for Kadcyla's ongoing review by the European Medicines Agency and other regulatory bodies around the world.

Dr Hal Barron, Roche's chief medical officer and head of global product development, said: "We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future."

Earlier this month, the company announced positive phase III trial data from the first stage of CLL11, a phase III trial investigating the efficacy of its new chronic lymphocytic leukaemia therapy obinutuzumab.

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