Kintara’s VAL-083 Receives the US FDA’s Fast Track Designation for the Treatment of Newly Diagnosed Glioblastoma

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The US FDA has granted FTD for VAL-083 to support the development and commercialization of VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma
Based on internal research programs and prior NCI-sponsored clinical studies, VAL-083 is currently evaluating an ongoing P-II/III study (GBM AGILE) and plans to present the data in the YE’23
VAL-083 is a first-in-class small molecule that showed clinical activity in various cancers incl. CNS, head and neck cancer, NSCLC, ovarian & bladder cancer in the US that were sponsored by the National Cancer Institute

Ref: PR Newswire | Image: Kintara