The FDA granted breakthrough therapy designation to DS-8201 for the treatment of HER-2-positive locally advanced or metastatic breast cancer that progressed after treatment with other HER-2-targeting agents.
The agency based the designation on preliminary evidence from a phase 1 study designed to evaluate the safety, tolerability and efficacy of DS-8201 (Daiichi Sankyo), an investigational HER-2-targeting antibody-drug conjugate.
The trial included patients with HER-2-positive metastatic breast cancer who received trastuzumab (Herceptin; Genentech) and pertuzumab (Perjeta, Genentech), and also experienced disease progression after treatment with ado-trastuzumab emtansine (Kadcyla; Genentech).
The researchers observed no dose-limiting toxicities, and the maximum tolerated dose was not reached.
“The breakthrough therapy designation for DS-8201 in HER-2-positive metastatic breast cancer acknowledges the unmet medical need these patients face when currently approved treatments no longer control their disease,” Antoine Yver, MD, MSc, executive vice president and global head of oncology research and development at Daiichi Sankyo, said in a company-issued press release. “We remain committed to rapidly progressing the development of DS-8201 and look forward to working closely with the FDA to potentially bring this new treatment option to patients with metastatic breast cancer as quickly as possible.”