GenFleet Therapeutics Announces GFH009 Granted with FDA Fast Track, Orphan Drug Designations for Treating R/R Peripheral T-cell Lymphomas and Acute Myeloid Leukemia

SHANGHAI, Jan. 11, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009). GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML). At present, two phase II studies are actively underway in China and the US, focusing on the treatment of r/r PTCL and r/r AML respectively. Numerous subjects in GFH009 studies achieved complete or partial responses, and superior safety profile & efficacy of GFH009 was observed in previous studies.

Read more at prnewswire.com