Personalized Lymphoma Vaccine Is Granted Orphan Drug Status in the United States

Zosia Chustecka

January 13, 2010

January 13, 2009 — A personalized vaccine for lymphoma, BiovaxID (developed by Biovest International), has been granted orphan drug status by the US Food and Drug Administration, which will grant it a 7-year period of market exclusivity after approval. It is one of a few late-stage patient-specific cancer vaccines vying to be the first to reach the market, according to the manufacturer.

The product showed an improvement in disease-free survival in a phase 3 clinical trial, which was reported at the American Society of Clinical Oncology (ASCO) 45th Annual Meeting, as reported by Medscape Oncology. Biovest says it plans to use these data to file for approval in the United States by mid-2010, and also plans to file for approval in Europe and Japan.

BiovaxID is personalized for each patient with a tumor-derived idiotype protein, and induces cellular immunity, which offers a different approach to treatment than existing immunotherapies. But the question of where it fits alongside existing therapy is the main issue, according to Ron Levy, MD, chief of oncology at Stanford University in California, and a pioneer in idiopathic vaccine development. He discussed the phase 3 data on BiovaxID at the ASCO meeting, and said that this trial showed that "the vaccine was effective in those patients in whom it was tested." But since that trial began, many years ago, the treatment of lymphoma has changed substantially, in particular after the introduction of rituximab, which has had a huge impact on this disease. The question of what role BiovaxID could play in the current treatment of lymphoma will need further study, Dr. Levy said.

Another commentator suggested that future studies would need to compare the vaccine with rituximab and chemotherapy. Dr. Sonali Smith, MD, associate director of the lymphoma program at the University of Chicago Medical Center in Illinois, suggested that using the vaccine would be "cumbersome" because it necessitates taking a fresh biopsy to generate the individualized vaccine for each patient.

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