Kintara Therapeutics Granted Fast Track Designation from the FDA for VAL-083 for Newly-Diagnosed Glioblastoma

On June 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM) (Press release, Kintara Therapeutics, JUN 15, 2022, View Source [SID1234615995]).

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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. Some of the significant benefits of FTD include:

Enhanced access to the FDA, including opportunities for more frequent meetings and written consultation throughout the remaining development of VAL-083.
Drugs with FTD 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.
FTD 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," stated Robert E. Hoffman, President and CEO of Kintara. "We look forward to announcing top-line data from the international registrational phase 2/3 GBM AGILE Study around the end of calendar year 2023. Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved."