FDA Grants Fast-track Status to New Antibody Therapy for HER2-Positive Advanced Breast Cancer

FDA Grants Fast-track Status to New Antibody Therapy for HER2-Positive Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted fast-track status to Daiichi Sankyo’s investigational therapy DS-8201a for patients with HER2-positive advanced breast cancer whose disease progressed after other HER2 therapies, such as Kadcyla (ado-trastuzumab emtansine). Fast-track designation is meant to facilitate the development of, and expedite the review of, therapies for treating serious conditions in situations where there is an unmet medical need. The purpose is to get important new therapies to patients earlier. "This is an important milestone for DS-8201 that underscores the critical need to develop new and effective therapeutic options for patients with metastatic breast cancer whose tumors are no longer controlled by currently approved targeted HER2 treatments," Antoine Yver, MD, MSc, executive vice president and global head of Daiichi Sankyo's Oncology Research and Development unit, said in a press release. "It's our obligation to drive science forward to help bring innovative treatment options to cancer patients with the greatest unmet needs and we look forward to working closely with the FDA to optimize development of DS-8201." DS-8201a kills cancer cells by attaching  anti-HER2 antibodies to topoisomerase I inhi
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