Federal regulators agreed to new rules for a key clinical study on Dendreon's experimental prostate-cancer drug Provenge, fast-forwarding...
Federal regulators agreed to new rules for a key clinical study on Dendreon’s experimental prostate-cancer drug Provenge, fast-forwarding the study’s final results by one year.
The move does not change the Seattle company’s most optimistic target date for approval of its product, which would be based on interim data.
The U.S. Food and Drug Administration said previously it could give its blessing if an early review of the results shows the drug’s effectiveness at improving the survival rate of prostate-cancer patients.
A Dendreon executive said Wednesday the company still expects to present interim data in the second half of this year.
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Nevertheless, if the interim data fail to pass muster with the regulators, Provenge will have another chance when the final results are in next year, rather than in 2010.
“We have two very real shots on goal,” said Chief Financial Officer Greg Schiffman. The trial’s redesign “really accelerates the second one without hurting the first one.”
The news seemed to reassure investors: Dendreon stock surged 7.3 percent to $5.29 a share.
It was also a glimmer of hope for many prostate-cancer patients vexed by the FDA’s decision last May not to approve the drug for lack of sufficient proof of efficacy.
“It’s good news: sooner is better than later,” said McAdams Wright Ragen analyst Paul Latta.
The redesign of the closely followed clinical trial is the latest episode in the Provenge saga, which has been at the epicenter of an intense debate over whether the FDA’s approval of potentially lifesaving drugs should be sped up or made stricter after recent safety scandals.
Hopes for Provenge rode high last March, after an expert panel recommended the drug.
But in May the FDA said more information was needed, making Dendreon shares plummet.
Patient advocates and angry investors accused some panel members of lobbying against Provenge due to conflicts of interest.
The advocates — through organizations like CareToLive and A Right To Live — have waged a vigorous campaign against the FDA that included demonstrations, lawsuits, and Freedom of Information Act requests for internal agency documents.
Three members of Congress requested hearings, but in February a congressional committee declined to look into the matter so as not to interfere with the agency’s regulatory process.
The move to speed up the clinical trial was initiated by Dendreon as part of its business strategy, and is unrelated to the political controversies surrounding Provenge, Schiffman said.
Ángel González: 206-515-5644 or email@example.com