Dendreon Claims “Clear Hit” On Provenge, But Skeptics Await Data

From The Cancer Letter, April 17, 2009:

Dendreon Inc. announced April 14 that it has met the endpoint for approval of Provenge (sipuleucel-T), a vaccine for treatment of advanced prostate cancer.

The company didn’t disclose data on either efficacy or toxicity, pending a presentation scheduled for April 28 at the plenary session at the American Urological Association.

At a conference call with analysts, Dendreon’s President and CEO Mitchell Gold said that the data “meet the criteria and specifications” of the Special Protocol Assessment by FDA, thereby supporting renewal of the company’s approval filing.

Gold described the data as “an unambiguous hit on the primary endpoint of overall survival in terms of statistical significance.”

“It was a clear hit on a prespecified primary endpoint of overall survival,” Gold said. “The results were robust, and they held up to multiple sensitivity analyses.”

Prostate cancer experts contacted by The Cancer Letter said they are eagerly awaiting the release of trial data at AUA, and—more so—the contents of the application submitted to the agency should those become public.

Read more about the IMPACT trial's unconventional design and comments by Howard Sher, Walter Stadler, and Donald Berry in the April 17 issue (subscription or day pass required) from The Cancer Letter Archive at left.




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tags: drug development