07.07.10
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 advanced breast cancer whose disease had worsened after receiving at least two prior HER2-targeted treatments. The primary endpoint of the study was objective response rate (a complete or partial tumor shrinkage of at least 30%).
“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,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “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.”
Come to Contracting & Outsourcing 2010 and find out more about Roche/Genentech’s risk-based approach to CMO management!
The multi-center trial assessed single-agent T-DM1 in 110 women with HER2-positive advanced breast cancer whose disease had worsened after receiving at least two prior HER2-targeted treatments. The primary endpoint of the study was objective response rate (a complete or partial tumor shrinkage of at least 30%).
“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,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. “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.”
Come to Contracting & Outsourcing 2010 and find out more about Roche/Genentech’s risk-based approach to CMO management!