FDA Puts Eganelisib on Fast Track for Advanced Triple-negative Breast Cancer

FDA Puts Eganelisib on Fast Track for Advanced Triple-negative Breast Cancer
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 Pharmaceuticals, in combination with the checkpoint inhibitor Opdivo (nivolumab) as a treatment for advanced urothelial cancer. “Fast Track designation is an exciting regulatory milestone that bolsters our momentum in TNBC,” said Adelene Perkins, Infinity's CEO, in a press release. Eganelisib is an oral, once-daily selective inhibitor of phosphoinositide-3-kinase gamma (PI3
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