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news.Dendreon has confirmed that the FDA will accept either a positive interim or final analysis of survival from its ongoing study for final approval of Provenge, which the company believes it can submit in 2008.
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The FDA requested additional clinical data for the licensure of Provenge, the company’s prostate cancer vaccine, after Dendreon submitted its marketing authorization application. Dendreon cut 40 marketing jobs following the setback, and expects to record non-cash charges of $300,000 and cash charges of $1.5 million as a result of the cuts.
Provenge, an investigational immunotherapy designed to stimulate a patient’s own immune system, has been developed for advanced prostate cancer. Patient groups have been pressurizing the FDA to make the drug available, as there are a lack of treatment options available to this group.
“The FDA indicated that either a positive interim or final analysis of survival, as described in the IMPACT Special Protocol Assessment Agreement, would address their request for the submission of additional clinical data in support of our efficacy claim,” said Mitchell Gold, president and CEO of Dendreon.
“We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making Provenge available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options.”