Allogene Gets FDA Fast-Track Designation for ALLO-316 in Renal Cell Carcinoma

By Colin Kellaher

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%.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

03-10-22 0902ET