Oral Mucositis Drug Is Under Review by the FDA

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The Food and Drug Administration agreed to speed up the review of avasopasem to treat severe oral mucositis in patients with head and neck cancer.

The Food and Drug Administration (FDA) granted a priority review for a new drug application to avasopasem, a drug that would treat severe oral mucositis in patients with head and neck cancer who are undergoing standard-of-care radiotherapy.

definition of oral mucositis, new drug application, priority review and standard of care

By granting a priority review, the FDA is agreeing to work closely with Galera Therapeutics — the pharmaceutical company developing the drug — to expedite the evaluation and potential approval of avasopasem. The FDA set a target date of Aug. 9, 2023 to decide on the drug’s approval.

Oral mucositis is a side effect from cancer treatment that involves inflammation and irritation of the mouth. It can be extremely painful and make it difficult for patients to swallow or talk. There are currently no FDA-approved therapies for oral mucositis in patients undergoing radiation therapy for head a neck cancer — a population that is highly likely to experience the side effect.

“Each year approximately 42,000 U.S. patients with (head and neck cancer) are at high risk of developing (severe oral mucositis) as a part of their cancer treatment,” Dr. Mel Sorensen, president and CEO of Galera Therapeutics, said in a press release. “The impact of (severe oral mucositis), the most burdensome toxicity of standard-of-care (radiation therapy), 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, (severe oral mucositis) is so debilitating that they may delay and/or discontinue potentially curative RT, undermining their care.”

The new drug application is based off two randomized, double-blind (meaning that neither the patients nor their treating clinicians know which group they are in), placebo-controlled trials (ROMAN and GT-201) that involved a total of 678 patients. Study findings showed that avasopasem decreased the burden of severe oral mucositis, as well as the incidence and number of days that patients experienced the side effect.

Additionally, patients who were given avasopasem tended to have decreased severity of oral mucositis, particularly in grade 4 mucositis, which prevents people from being able to eat. Those given the drug also had a delayed onset of the side effect.

Findings from the ROMAN trial also showed another benefit of avasopasem: it reduced the incidence of chronic kidney injury caused by cisplatin, a type of chemotherapy. In both studies, however, there was a slight increase in the rate of hypotension (low blood pressure) and mild nausea for those who were taking avasopasem.

“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,” Sorensen said in the release.

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