MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review to the New Drug Application (NDA) for avasopasem manganese for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. There are currently no FDA-approved drugs to reduce SOM for these patients. With the 6-month priority review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for this NDA is August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.
The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of SOM induced by RT.
“We are very pleased by the FDA’s acceptance of our NDA with priority review, which is a significant milestone as we prepare to bring this important product, if approved, to patients as soon as possible, and we look forward to working closely with the FDA during the review process,” said Mel Sorensen, M.D., President and Chief Executive Officer of Galera Therapeutics.
Dr. Sorensen continued: “Each year approximately 42,000 U.S. patients with HNC are at high risk of developing SOM as a part of their cancer treatment. The impact of SOM, the most burdensome toxicity of standard-of-care RT, on a patient’s physical and psychological wellbeing is substantial, particularly when hospitalization and surgical placement of feeding tubes to maintain nutrition and hydration are required. In some patients, SOM is so debilitating that they may delay and/or discontinue potentially curative RT, undermining their care. Avasopasem, if approved, has the potential to reduce pain and suffering for these patients, as well as reduce the costs associated with hospitalizations, surgical placement of feeding tubes, and other treatment burdens.”
The NDA is supported by two randomized, double-blind, placebo-controlled trials (Phase 3 ROMAN and Phase 2b GT-201), which enrolled a total of 678 patients. Both trials demonstrated clinically meaningful reductions across key measures of patients’ SOM burden, including decreasing the incidence and number of days of SOM, decreasing the severity (incidence of Grade 4 oral mucositis, the inability to eat or drink), and delaying the time to SOM onset. In addition, follow-up data that was collected on renal function through 12 months post administration of RT and avasopasem point to another clinically meaningful benefit for these patients, most of whom receive cisplatin chemotherapy as part of their care. In the ROMAN trial, results on a pre-defined exploratory endpoint showed that avasopasem reduced cisplatin-induced chronic kidney disease by half at one year.
In both trials, the reported side effects were consistent with those caused by RT and cisplatin, other than some increases in rates of hypotension and mild nausea with avasopasem. There were nominal decreases in the rates of some side effects associated with RT or with cisplatin among avasopasem patients in the combined trials, such as oropharyngeal pain, radiation skin injury, tinnitus, and acute kidney injury.
After long-term follow-up in both trials, patients treated with avasopasem in combination with the standard-of-care regimen (RT plus cisplatin) demonstrated comparable tumor outcomes and overall survival to patients in the placebo arm, showing that avasopasem protected HNC patients from SOM without affecting the treatment benefit of standard-of-care chemoradiotherapy.
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