FDA Fast Track designation for photodynamic cancer therapy

REM-001, a photodynamic therapy for cutaneous metastatic breast cancer has been given Fast Track designation by the US Food and Drug Administration (FDA).

FDA Fast Track designation for photodynamic cancer therapy

Fast Track designation (FTD) has been granted for REM-001 therapy to treat unresectable cutaneous metastatic breast cancer (CMBC) by the US Food and Drug Administration (FDA).

If marketed, REM-001, produced by Kintara Therapeutics, could be a potential therapy for advanced breast cancer patients who have limited treatment options. The drug was evaluated in four Phase II/III clinical trials in patients previously given chemotherapy and/or failed radiation therapy. According to Kintara Therapeutics, REM-001 demonstrated a complete response in approximately 80 percent of evaluable CMBC tumour sites in previous trials.

REM-001 therapy for cutaneous metastatic breast cancer

Kintara states REM-001 therapy is a photodynamic therapy (PDT) photosensitiser agent consisting of three parts: a laser light source, the drug REM-001 and a light delivery device that uses a fibre optic wand. When exposed to specific wavelengths of light, the PDT acts as a catalyst to produce reactive oxygen species (ROS), which induces local tumour cell death by activating immune response, apoptosis, antiangiogenesis and necrosis.

FTD facilitates drug development and can expedite the review of drugs for serious conditions to help address unmet medical needs. The FTD enables Kintara Therapeutics access to more frequent meetings and written consultation with the FDA to support development of REM-001 as a treatment for breast cancer. In addition, this means REM-001 is eligible for Accelerated Approval and Priority Review later on in the development process, potentially allowing the therapy to be approved in a shorter amount of time.

“Fast Track Designation represents an important regulatory milestone for our REM-001 therapy programme,” asserted Robert E Hoffman, President and CEO of Kintara.

Dennis Brown, PhD, Chief Scientific Officer of Kintara added: “This designation from the FDA emphasises the important unmet medical need for safe and effective therapeutic options to address CMBC.”

Currently, Kintara is preparing for a future Phase III study to further assess the effects of REM-001.