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news.The FDA has granted fast track status to Biovest International's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma, BiovaxID.
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The targeted anticancer immunotherapy is now undergoing pivotal phase III clinical trials at over 20 major medical centers throughout the US. The drug showed very positive phase II results with 95% of patients still alive more than nine years after being treated with Biovax ID.
Biovest is now eligible to submit a biologics license application (BLA) on a rolling basis, allowing the FDA to review sections of the BLA in advance of receiving the company’s full submission, and permitting Biovest to apply for an expedited review of its BLA.
“In its letter to us the FDA has indicated that BiovaxID shows the potential to treat a serious and life threatening condition and that our clinical development plan is designed to demonstrate an improvement in disease free survival and an effect on overall survival. This action by the FDA will help us bring BiovaxID to patients more quickly by allowing us to move our regulatory filing forward in stages,” said Dr Steve Arikian, chairman and CEO of Biovest.