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.”