Biovest International was granted orphan drug designation by the FDA for BiovaxID, its vaccine for the immunization of patients against mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. The grant of orphan drug status for mantle cell lymphoma was based on a Phase 2 trial that demonstrated promising results. In this trial, tumor-specific immune responses were observed in 87% of the patients vaccinated with BiovaxID following rituximab-containing chemotherapy (EPOCH-R). Consistent with all other BiovaxID studies, the vaccine was very well tolerated and safe.
BiovaxID is a patient-specific, cancer vaccine that has been previously granted Fast Track status and orphan drug designation for patients suffering from indolent follicular non-Hodgkin’s lymphoma.
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