FDA fast track for Biovest's BiovaxID

The US Food and Drug Administration has granted Fast Track status to BiovaxID, Massachusetts-based Biovest International's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma.

The targeted anticancer immunotherapy, now undergoing pivotal Phase III clinical trials at over 20 major medical centers throughout the USA, showed extremely positive Phase II results as, more than nine years after treatment with BiovaxID, 95% of patients are still alive, the company stated.

Biovest is currently enrolling patients for a Phase II BiovaxID study, which is being run in collaboration with the National Cancer Institute through a Cooperative Research and Development Agreement.