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news.Genentech, a member of the Roche Group, has filed a biologics license application (BLA) to the FDA for trastuzumab-DM1 (T-DM1) to treat patients with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.
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Genentech’s filing of BLA is based on T-DM1 Phase II study results, which showed T-DM1 shrank tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer.
T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody, being studied for advanced HER2-positive breast cancer.
T-DM1 attaches trastuzumab and the chemotherapy DM1 along with using a stable linker, which is designed to keep T-DM1 in one piece until it reaches specific cancer cells.
Hal Barron, executive vice president of global development and chief medical officer, said: “While we’ve made great strides in treating HER2-positive breast cancer, there is a group of people whose breast cancer will come back after many treatments, leaving them with very limited options.
“Data from studies have shown that T-DM1 shrank tumors in these people, so we are excited to have submitted this application to the FDA in hopes of offering a potential new medicine to people with this type of breast cancer.”