Galera Priority Review for Oral Mucositis Drug

FDA has accepted for priority review a Galera Therapeutics NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment. The agency has set an 8/9 user fee review action target date.

The submission is based on data from two randomized, double-blind, placebo-controlled trials (Phase 3 ROMAN and Phase 2b GT-201), which enrolled 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,” the company says.

On the safety side, reported side effects were “consistent with those caused by radiotherapy and cisplatin, other than some increases in rates of hypotension and mild nausea with avasopasem,” Galera says.