FDA grants fast track designation to REM-001 for cutaneous metastatic breast cancer
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The FDA granted fast track designation to REM-001 for the treatment of cutaneous metastatic breast cancer.
REM-001 (Kintara) is a late-stage photodynamic therapy platform being investigated to serve as a localized cutaneous — or visceral — tumor treatment, according to its manufacturer. The REM-001 therapy includes a laser light source, the light delivery device and the REM-001 drug product.
Researchers have investigated REM-001 in four phase 2 or phase 3 clinical trials of patients with cutaneous metastatic breast cancer who had already received a previous round of chemotherapy and/or failed radiation therapy.
“This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address [cutaneous metastatic breast cancer],” Dennis Brown, PhD, chief scientific officer of Kintara Therapeutics, said in a press release. “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.”
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