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Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait
Center for Applied Medical Research and University Hospital, University of Navarra, Avda. Pio XII 36-55, 31008 Pamplona, Spain
Current address: Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-8590, USA
Received: 5 February 2010; in revised form: 3 March 2010 / Accepted: 8 March 2010 / Published: 15 March 2010
Abstract: Hybridoma-derived idiotype vaccines have been used for the experimental treatment of human lymphoma over the last twenty years, providing evidence of biological efficacy, clinical efficacy and clinical benefit. However, the product that has come closer to regulatory approval is unlikely to clear that hurdle due to the insufficiently robust data obtained in a recently closed clinical trial. This review aims at discussing the reasons for hybridoma-derived idiotype vaccines, more difficult to produce but also more successful than recombinant idiotype vaccines so far, are unlikely to gain regulatory approval. In particular, it is necessary to examine the many peculiar features of this therapeutic approach in a broader context, with special attention to concepts like customized active immunotherapy and randomization. Most published trials based on hybridoma-derived idiotype vaccines are being analyzed, together with the yet non-peer reviewed data from the only randomized study conducted so far with this product, and with the main trials on recombinant idiotype vaccines for thorough comparison. All in all, the sole randomized trial ever conducted on hybridoma-derived idiotype vaccines failed to achieve its primary clinical end point because of an insufficient accrual and because the statistical significance achieved was not as stringent as required for regulatory approval.
Keywords: hybridoma; idiotype; immune response; lymphoma; randomized trials; recombinant; vaccine
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MDPI and ACS Style
Bendandi, M. Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait. Pharmaceuticals 2010, 3, 667-678.
Bendandi M. Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait. Pharmaceuticals. 2010; 3(3):667-678.
Bendandi, Maurizio. 2010. "Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait." Pharmaceuticals 3, no. 3: 667-678.