Allogene Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration granted fast-track designation to its ALLO-316 drug candidate for the treatment of advanced or metastatic clear cell renal cell carcinoma.
The South San Francisco, Calif., clinical-stage biotechnology company said the designation is based on the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat renal cell carcinomas who have failed standard therapies.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Allogene said current therapies for renal cell carcinoma, A type of kidney cancer that starts in the lining of small tubes in the kidney, are based on a few mechanistic targets, and complete response rates are low. The company said the five-year survival rate for patients with advanced kidney cancer is less than 15%.
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