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SELLAS Life Sciences Receives Fast Track Designation from FDA for SLS009 for Treatment of Relapsed/Refractory Peripheral T-cell Lymphomas
- SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL Patients with Standard of Care is 25.8% - - Fast Track Designation Accelerates SLS009's Path to U.S. FDA Submission for Treatment of r/r PTCL - NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL). The Fast Track designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need. “The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed dose-escalation portion of the Phase 1 trial in relapsed/refractory hematological malignancies and with the Fast Track designation we are poised to accelerate its development. We are committed to working closely with the FDA and our partner GenFleet Therapeutics to develop this promising treatment for patients in need.” SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy in the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies. Complete or partial responses were observed in acute myeloid leukemia and lymphoma patients among which four out of eleven patients with PTCL (36.4%) achieved clinical responses including one in continuous treatment for over 56 weeks. The current standard of care for PTCL, belinostat, approved for r/r PTCL, showed in its pivotal Phase 2 study a 25.8% response rate in a similar patient po...