FDA Grants Fast Track Designation to Kintara for VAL-083 for Newly-Diagnosed Glioblastoma
June 15, 2022
The U.S. Food and Drug Administration granted Fast Track designation to Kintara Therapeutics’ VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM), a rare aggressive brain cancer.
VAL-083 is a first-in-class, small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian, and other solid tumors in U.S. clinical trials sponsored by the National Cancer Institute. Based on Kintara’s internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently advancing VAL-083 in the Global Coalition for Adaptive Research registrational phase 2/3 clinical trial titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study to support the development and commercialization of VAL-083 in GBM.
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Benefits include enhanced access to the FDA with opportunities for more frequent meetings and written consultation throughout the remaining development of VAL-083. Drugs with Fast Track designation are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval. The designation also allows for rolling review, whereby Kintara may submit completed sections of the VAL-083 NDA as they become available, rather than at the end of development.
“We believe Fast Track designation is indicative of VAL-083’s potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer,” said Robert Hoffman, president and CEO of Kintara. “Fast Track designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved.”
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