FDA fast-tracks Genitope’s MyVax

Under the fast track designation, the FDA will help expedite the development and review of the MyVax personalized immunotherapy biologics license application (BLA) for approval. The regulator may also begin review of portions of a BLA in advance of the full submission.

MyVax will also be eligible for priority review, which provides for a six-month review of the BLA by the FDA.

“Securing fast track designation for MyVax personalized immunotherapy in advance of the phase III study interim analysis this summer is especially meaningful and puts us one step further down our pathway toward commercialization,” said Dr Dan Denney, Jr, CEO of Genitope.

Genitope initiated a phase III pivotal trial evaluating MyVax personalized immunotherapy in stage III/IV follicular non-Hodgkin’s Lymphoma (fNHL) patients. The pivotal trial was based upon encouraging results from three separate phase II trials evaluating the long-term efficacy of the treatment.