FDA grants fast track designation to RV001 for prostate cancer
The FDA granted fast track designation to RV001 for the treatment of prostate cancer.
RV001 (RhoVac) is a peptide-based immunotherapy designed to train the immune system to target cancer cells with metastatic potential.
Men treated for prostate cancer undergo surveillance but have no access to preventive therapy. Upon disease recurrence, men are eligible for additional treatment, such as hormone therapy.
RV001 is intended to reduce recurrence and delay progression among men whose disease does recur.
A phase 2B trial is underway to evaluate the therapy for prostate cancer. The study, designed to include more than 175 men from the United States and Europe, is expected to conclude in early 2022.
“We obviously appreciate the benefits that this [fast track designation] might entail in terms of access to FDA advice and an accelerated approval process,” Anders Månsson, CEO of RhoVac, said in a company-issued press release. “The fact that the FDA has reviewed our data and found our drug candidate worthy of this level of priority obviously sends a clear signal of recognition of the drug’s potential to all our would-be partners, which is something of great importance to us.”