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# Sellas Life Sciences Gets Fast Track
- URL: https://www.fdaweb.com/sellas-life-sciences-gets-fast-track/
- Published: 2024-01-10T12:00:00.000Z
- Updated: 2026-09-14T14:19:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156117

FDA has granted Sellas Life Sciences a fast track designation for SLS009 (formerly GFH009), a highly selective CDK9 inhibitor for treating relapsed/refractory acute myeloid leukemia (AML).

The designation is based on topline Phase 2a data that showed SLS009 in combination with venetoclax and azacitidine have “anti-leukemic effects with a favorable safety profile in AML patients resistant to venetoclax combination therapies,” according to the company. “Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive.”

The company says additional data from the fully enrolled 45 mg (safety dose level) cohort and initial data from the 60 mg (recommended Phase 2 dose level) cohort is expected by April.