SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
Retrieved on:
Thursday, December 21, 2023
NEW YORK, Dec. 21, 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 Orphan Drug Designation (ODD) for SLS009, the Company’s novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL).
Key Points:
- “We are delighted to announce the FDA’s granting of ODD for SLS009, marking another significant milestone following the recent Fast Track Designation by the FDA for PTCL,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
- “In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 achieved clinical responses in PTCL including two patients reaching complete response.
- The patients who achieved complete response in the SLS009 study were previously treated with regimens containing an HDAC inhibitor.
- These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.