Kintara Therapeutics, Inc. announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara's REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC). REM-001 was studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to-date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is focused on securing the funding necessary to restart a 15-patient study in CMBC patients in advance of a Phase 3 study.

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 REM-001. 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' where Kintara may submit completed sections of the REM-001 NDA as they become available rather than at the end of development.