Genentech Submits T-DM1 BLA

Genentech has submitted a BLA to the FDA for trastuzumab-DM1 (T-DM1) to treat advanced HER2-positive breast cancer in patients that previously received multiple HER2-targeted medicines and chemotherapies.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Genentech has submitted a BLA to the FDA for trastuzumab-DM1 (T-DM1) to treat advanced HER2-positive breast cancer in patients that previously received multiple HER2-targeted medicines and chemotherapies. This submission is based on results from a Phase II study showing that T-DM1 shrank tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer. The multi-center trial assessed single-agent T-DM1 in 110 women with HER2-positive adva...

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