The U.S. Food and Drug Administration has granted fast track status to immuno-oncology candidate eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy as a first-line treatment for patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC). Fast track designation speeds clinical development, regulatory review, and marketing approval of potential medications for serious medical conditions with unmet needs. The FDA previously granted fast track status to eganelisib, which is being developed by Infinity…
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