The application to the FDA follows the completion of a randomized, parallel-group, open-label, multicenter Phase III clinical trial that evaluated time to progression (TTP) of the disease with combination versus monotherapy docetaxel treatment.
The study met its protocol-specified primary endpoint demonstrating that the Doxil-docetaxel combination had a statistically significant improvement in TTP as compared to docetaxel alone. Secondary endpoints included overall survival, response rates and safety.
Craig Tendler, vice president of medical affairs for oncology and nephrology at Ortho Biotech Products, said: “This is an important milestone in the development of Doxil as we continue to demonstrate efficacy and safety of this agent across multiple tumor types.
“We look forward to working with the FDA throughout the regulatory review process to provide this new Doxil treatment option for advanced stage breast cancer patients who have relapsed after receiving prior anthracycline-containing adjuvant/neoadjuvant therapy.”