25.02.2013 - Roche has received the OK to market its breast cancer antibody-drug conjugate T-DM1 in the US under the brand name Kadcyla.
The FDA granted the approval for Kadcyla monotherapy plus Xeloda (capecitabine) of Her2-positive women with metastatic breast cancer, who had already been treated with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is composed of the antibody, trastuzumab which is linked to the chemotherapeutic DM1 and targets the toxin, which kills proliferating cells, to the tumour.
“Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “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.”
Roche currently has eight ADCs in early clinical testing for different types of cancer. Roche has also submitted a Marketing Authorisation Application to other Regulatory Authorities around the world, including the European Medicines Agency (EMA). The FDA approval of Kadcyla is based on results from EMILIA (TDM4370g/BO21977), an international, Phase III, randomised, open-label study comparing Kadcyla alone to lapatinib – the current standard of care – in combination with Xeloda (capecitabine) in 991 people with HER2-positive locally advanced breast cancer previously been treated with Herceptin and a taxane chemotherapy. The study met both co-primary efficacy endpoints of overall survival and progression-free survival.
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