The Provenge Precedent
This article was originally published in RPM Report
Dendreon's therapeutic cancer vaccine Provenge is the first of its kind to make it to an FDA advisory committee. The committee gave the novel agent a thumbs up. But FDA may disagree and turn away the prostate cancer vaccine until there is more conclusive data of its safety and effectiveness. How much does Dendreon stand to lose?
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It appeared as though the controversy over the level of efficacy and benefit from the prostate cancer immunotherapy Provenge ended when the drug was approved by FDA at the end of April. The FDA approval may have just been the halfway point in the product's route through government agencies to the commercial market. Now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Provenge and pirfenidone were two of the most closely watched pending applications at FDA. The agency's decision on the two therapies may offer some insight into the current regulatory climate.
Several of the highest profile new drug applications pending or expected to be submitted as 2010 begins involve potential blockbuster market opportunities. They also lack Big Pharma partners. Is Big Pharma really that picky? Or are the applications out of step with the regulatory and commercial climate? Either way, intense investor interest will keep FDA in the spotlight.