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FDA grants breakthrough therapy designation to GC4419 for severe oral mucositis
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The FDA granted breakthrough therapy designation to GC4419 for the reduction of the duration, severity and incidence of severe oral mucositis induced by radiation therapy, according to a press release from the therapy’s manufacturer.
About 70% of patients with head and neck cancer receiving radiotherapy develop severe oral mucositis, caused by excessive superoxide. There is no approved treatment for severe oral mucositis.
GC4419 (Galera Therapeutics) — a selective and potent molecule dismutase mimetic — converts the superoxide generated by radiotherapy into hydrogen peroxide.
The FDA based the breakthrough therapy designation on a double-blind, randomized, placebo-controlled phase 2b trial of 223 patients with head and neck cancer. Patients assigned GC4419 had a 92% reduction in duration of severe oral mucositis (from 19 days to 1.5 days). The therapy reduced incidence of severe oral mucositis by 34% and severity by 47% when added to standard radiotherapy treatment.
GC4419 also demonstrated an acceptable safety profile.
“Breakthrough therapy designation from the FDA further validates the meaningful efficacy and safety results GC4419 demonstrated in our recent phase 2b clinical trial and highlights the urgent need for a treatment option for severe oral mucositis,” Mel Sorensen, MD, president and CEO of Galera, said in the release. “We look forward to working closely with the FDA on the continued development of GC4419 for the reduction of [severe oral mucositis among] patients in order to efficiently advance the clinical program and ultimately bring GC4419 to patients in need.”
As HemOnc Today previously reported, the FDA granted GC4419 fast-track designation for reduction of radiation- and chemotherapy-induced oral mucositis.