The European Medicines Agency has designated Biovest International's BiovaxID vaccine as an orphan medicinal product for mantle cell lymphoma. The personalized cancer vaccine has received orphan drug status for the treatment of mantle cell lymphoma and follicular lymphoma in both the U.S. and EU.
With orphan drug status, Biovest has 10 years of marketing exclusivity for both diseases once the vaccine receives EMA approval. Two Phase II trials and one Phase III trial have already been completed.
"We believe mantle cell lymphoma is an ideal indication for BiovaxID to potentially provide significant clinical benefit for patients," explains Carlos Santos, Biovest's senior VP, Product Development & Regulatory Affairs, in a release. "Our clinical data, as reported last December at the American Society of Hematology (ASH) Annual Meeting, suggests that BiovaxID-treated patients who express a certain type of protein isotype called IgM on their lymphoma cells are much more likely to remain cancer-free longer after achieving a remission following induction therapy. Virtually all mantle cell lymphoma patients express this IgM isotype, so we look forward to advancing BiovaxID for the treatment of this aggressive blood cancer."
- see the Biovest release