FDA Grants Fast Track Status to Breast Cancer Therapy Candidate Balixafortide Combined with Halaven

FDA Grants Fast Track Status to Breast Cancer Therapy Candidate Balixafortide Combined with Halaven
The U.S. Food and Drug Administration granted fast track status to Polyphor’s immuno-oncology candidate balixafortide (POL6326) in combination with Halaven (eribulin mesylate) to treat a subset of patients with metastatic breast cancer. The combination is being evaluated in patients with HER2-negative metastatic breast cancer who previously took a minimum of two chemotherapy regimens while metastatic. Fast track designation is granted to speed up the development and review of potential medications for serious conditions and fill an unmet medical need. Treatment candidates that receive this designation benefit from more frequent communication with the FDA regarding clinical trials’ design and collection of all necessary data for approval. These therapies may also benefit from future accelerated approval and priority review. "We have already identified a development path for balixafortide with input from the FDA to conduct a single pivotal study in this indication. Fast Track designation is another positive step for the development of balixafortide and a recognition of the need for better treatments for this group of patients," Gia
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