Prima gets FDA fast-track status for CVac

Prima BioMed (ASX:PRR) has secured fast-track designation from the US FDA for cancer treatment candidate CVac in ovarian cancer.

The designation covers a clinical development program aiming to improve overall survival in patients with relapsed platinum-sensitive epithelial ovarian cancer in second complete remission.

Fast-track status will grant Prima advantages including more frequent meetings and correspondence with the FDA, and an entitlement to file its application for approval for the drug in stages rather than waiting until the whole application is completed.

Prima CEO called the designation an “important milestone” for the company. “The FDA decision is in recognition of the serious nature of ovarian cancer and the clear unmet medical need to develop new treatments for relapsed platinum-sensitive ovarian cancer in remission,” he said.

Prima is concentrating its efforts on this subset of ovarian cancer patients due to the outcome of its phase II CAN-003 trial. Early results indicated that this was the only group which demonstrated a statistically significant improvement in progression-free survival.

As a result, the company has changed the primary endpoint of its recently commenced CAN-004 trial to overall survival, and is concentrating recruitment in patients in second-line remission.

The FDA has also granted Prima orphan drug designation for CVac, and the product has orphan medicinal product designation from the European Medicines Agency.

Prima BioMed (ASX:PRR) shares were trading 30.56% higher at $0.047 as of around 1.30 pm on Friday.

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