On September 18, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that a Type A Meeting has been scheduled for September 28, 2023 with the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the Company’s New Drug Application (NDA) for avasopasem manganese (avasopasem) (Press release, Galera Therapeutics, SEP 18, 2023, View Source [SID1234635202]). The FDA is expected to issue written meeting minutes approximately 30 days following the meeting.
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"We look forward to further understanding the FDA’s review of our NDA for avasopasem and the data from our two randomized placebo-controlled clinical trials," said Mel Sorensen, M.D., Galera’s President and CEO. "We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis. With clarity on the perspective of the FDA reviewers from the meeting and subsequent minutes, we hope to identify necessary steps to bring avasopasem to these patients."
The Company intends to gain an understanding from the FDA of its evaluation of avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment and next steps to support an NDA resubmission. The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.