FDA selects Fate Therapeutics' FT819 for pilot program to speed manufacturing for lupus treatment

Fate Therapeutics announced that the FDA has chosen its FT819 therapy for the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program. This program supports faster manufacturing readiness for therapies with expedited clinical timelines, helping to accelerate FT819's development for treating moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis. FT819 is an off-the-shelf CAR T-cell therapy designed for outpatient use, aiming to improve accessibility for patients. The therapy also holds Regenerative Medicine Advanced Therapy (RMAT) designation, which alongside CDRP participation, may speed regulatory approval and commercial readiness as the company advances to Phase 2 clinical trials.