Kintara Therapeutics Granted Fast Track Designation from FDA for REM-001 for Cutaneous Metastatic Breast Cancer

On Nov 30, 2022

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.

“The receipt of Fast Track Designation represents an important regulatory milestone for our REM-001 Therapy program,” said Robert E. Hoffman, President and CEO of Kintara. “We believe this designation is a key component of our future clinical and regulatory strategy as we continue to seek funding, in particular grants, to restart REM-001 clinical development as soon as possible.”

Dennis Brown, Ph.D., Chief Scientific Officer of Kintara added, “This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address CMBC. We have extensive data in hand to support the advancement of this clinical program and look forward to the continued investigation of our drug candidate in the next study as planned.”

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.