BiovaxID given orphan designation for Waldenstrom’s


Biovest International, Inc. (owned by Accentia Biopharmaceuticals) has announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's lead oncology candidate, BiovaxID, for a rare subtype of non-Hodgkin's lymphoma.

BiovaxID is autologous active immunotherapy—a personalized cancer vaccine, in other words—that Biovest has been working on for several years and which has been developed by Dr. Larry Kwak, Chairman of the Department of Lymphoma/Myeloma at the MD Anderson Cancer Center in Houston, Texas.

The subtype is Waldenstrom’s macroglobulinemia, an indolent B-cell non-Hodgkin's lymphoma that is typically treated with single-agent chemotherapy involving alkylating agents (such as chlorambucil), multiagent chemotherapy (involving vincristine, cyclophosphamide, and prednisone, with or without anthtacyclines), or possibly fludarabine.

Biovest's longer term aim is to receive FDA market approval for BiovaxID for the treatment of follicular lymphoma.

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