MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) announced the recent presentation on Friday, March 10, 2023, of a net treatment benefit analysis of Phase 3 ROMAN results at the 10th European Congress on Head and Neck Oncology (ECHNO). The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM). Galera’s New Drug Application (NDA) in the U.S. for avasopasem is currently under U.S. Food and Drug Administration (FDA) priority review for radiotherapy (RT)-induced SOM in patients with head and neck cancer undergoing standard-of-care treatment.
“We are pleased to present at ECHNO the results of the Phase 3 ROMAN trial, including a net treatment benefit analysis submitted as part of Galera’s NDA,” said Mel Sorensen, M.D., President and Chief Executive Officer of Galera Therapeutics. “This analysis is particularly appropriate for SOM, where we believe that no single endpoint fully characterizes the potential impact of SOM on patient quality of life. We believe the results reinforce avasopasem’s first-in-class potential to reduce SOM, a common and debilitating effect of radiotherapy in patients with head and neck cancer. As we work with the FDA on the potential to bring avasopasem to U.S. patients, we also look forward to discussions with European regulatory authorities on a path for patients in Europe.”
Results from two randomized, double-blind, placebo-controlled trials (Phase 3 ROMAN and Phase 2b GT-201) are the basis of the avasopasem NDA. The Company believes that the supplemental net treatment benefit analysis being presented at ECHNO further supports the avasopasem clinical benefit observed in those trials. It quantitatively demonstrates that the overall improvement in SOM is greater than that captured by any individual endpoint and that the improvement in each of the key SOM endpoints contributes to the benefit. The FDA accepted the filing and granted priority review to the NDA in February 2023, with a PDUFA target date of August 9, 2023. The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of RT-induced SOM.
Head and neck cancers are a global problem, as is SOM caused by the standard-of-care RT. The Company intends for avasopasem to help patients beyond the U.S. and plans to meet with the European Medicines Agency (EMA) in 2023 to discuss the potential European registration pathway for avasopasem.
The presentation is available on Galera’s website at https://www.galeratx.com/our-pipeline/key-publications.
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