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news.Genentech has gained US marketing rights for Kadcyla (ado-trastuzumab emtansine or T-DM1), an antibody-drug conjugate (ADC), following the regulatory approval from the US Food and Drug Administration (FDA).
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Kadcyla, which is designed by joining trastuzumab antibody with a chemotherapy drug DM1 using a stable linker, is indicated for use for the treatment of HER2-positive metastatic breast cancer (mBC).
The FDA approval was based on the positive results from an international, randomized, open-label Phase III EMILIA (TDM4370g/BO21977) study, which enrolled patients with HER2-positive locally advanced breast cancer and who had previously been treated with Herceptin (trastuzumab) and a taxane chemotherapy.
The study compared Kadcyla alone to lapatinib in combination with Xeloda (capecitabine) in 991 patients and found out that patients treated with Kadcyla had a median progression-free survival of 9.6 months compared to 6.4 months in patients treated with lapatinib plus capecitabine.
The study also reported median overall survival of 30.9 months in the Kadcyla group compared to 25.1 months in patients treated with lapatinib plus capecitabine.
Genentech, which has licensed technology for Kadcyla under an agreement with ImmunoGen, is expecting to launch Kadcyla in the US within two weeks.
The company has also submitted its Kadcyla’s marketing authorization application, which is currently under review by the European Medicines Agency (EMA).