FDA grants priority review to Avasopasem for radiotherapy-induced severe oral mucositis
Source: www.onclive.com/ Author: Chris Ryan The FDA has granted priority review to the new drug application (NDA) for avasopasem manganese (GC4419) as a treatment for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment.1 The NDA was supported by data from the phase 2b GT-201 (NCT02508389) and phase 3 ROMAN (NCT03689712) trials, which enrolled a total of 678 patients. Findings from GT-201 demonstrated that 90 mg avasopasem induced a significant reduction in median SOM duration compared with placebo (1.5 vs 19 days; P = .024).2 Additionally, 43% of patients treated with avasopasem experienced SOM compared with 65% of patients who received placebo (P = .009). Grade 4 instances of SOM occurred in 16% and 30% of patients in the avasopasem and placebo arms, respectively (P = .045). In the ROMAN confirmatory trial, avasopasem also significantly reduced incidence of SOM.3 Data presented during the 2022 ASCO Annual Meeting showed that through the course of intensity-modulated radiation therapy (IMRT), SOM was reported in 54% of patients administered avasopasem (n = 241) vs 64% of those given placebo (n = 166; relative risk [RR], 0.84; P = .045), meeting the trial’s primary end point. Additionally, when avasopasem was given prior to IMRT, patients experienced a 56% reduction in median duration of SOM compared with placebo (8 vs 18 days, respectively; P = .002). Compared with placebo, these patients also had a 27% reduction in incidence of grade 4 SOM (33% vs 24%; P = .052) and a [...]