Pharmaceutical Business review

FDA grants fast track status for Prima BioMed’s CVac

The company said it will work closely work with the FDA in accelerating its development program for CVac to potentially bring this treatment option to patients in the US.

Prima CEO Matthew Lehman said 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.

"Building from our CAN-003 trial data, which indicated an improvement in progression-free survival in this patient population, we look forward to accelerating our recently commenced CAN-004-B trial to establish overall survival advantages of CVac as soon as possible," Lehman said.

The FDA fast track status for CVac comes in addition to the orphan drug designation previously awarded by the FDA in September 2010.

The orphan drug status is intended to provide incentives to encourage companies to pursue cures and treatments for rare diseases by providing major benefits during the product commercialisation process.

The company said that CVac has an additional designation to facilitate its delivery to patients.

In June 2010, the European Medicines Agency (EMA) had granted CVac orphan medicinal product designation, which provides major benefits during product commercialisation.