FDA approves Genentech’s Kadcyla

22-Feb-2013

First antibody-drug conjugate (ADC) for Her2-positive metastatic breast cancer

The US Food and Drug Administration (FDA) has approved Genentech’s Kadcyla (ado-trastuzumab emtansine or T-DM1), an antibody-drug conjugate (ADC) for the treatment of HER2-positive metastatic breast cancer (mBC).

The drug is targeted at patients who have previously received treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Genentech, the biotechnology division of Roche, said Kadcyla would be available in the US within two weeks.

Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease. It is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Genentech ADC to be approved by the FDA. Genentech says it has studied ADC science for more than a decade and has eight ADCs in Phase I or Phase II studies for different types of cancer.

The approval of Kadcyla is based on results from EMILIA (TDM4370g/BO21977), an international, Phase III, randomised, open-label study comparing Kadcyla with lapatinib in combination with Xeloda (capecitabine).

Genentech says the study met both co-primary efficacy endpoints of overall survival and progression-free survival.

Roche has also submitted a Marketing Authorisation Application for Kadcyla to other regulatory authorities around the world, including the European Medicines Agency (EMA), for the treatment of people with HER2-positive mBC.

Kadcyla is the fourth medicine from Genentech to receive FDA approval for people with advanced cancers within the past two years.

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The company licenses the technology for Kadcyla under an agreement with ImmunoGen.

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