Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care
This article was originally published in Pharmaceutical Approvals Monthly
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class
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CHICAGO - The Phase III results for Bristol-Myers Squibb's ipilimumab represent a breakthrough in melanoma, stole the show at the 2010 American Society of Clinical Oncology annual meeting and are generally expected to presage the first approval of a CTLA-4 inhibitor and the first approval in the disease for more than a decade. But the unexpectedly lackluster performance of an experimental vaccine used with the trial drug and as a control has created some interesting clinical and regulatory plot twists
FDA found the uncertainty expressed by the advisory committee reviewing Dendreon’s Provenge to be a better guide for regulatory action than the panel’s numerical vote supporting approval, according to the FDA review documents for the first autologous cancer vaccine.
Danish firm won license for the therapy, once held by defunct Therion, in CRADA with NCI.