RandyW Posted May 10, 2007 Share Posted May 10, 2007 NEW YORK, May 9 (Reuters) - Pharmacyclics Inc. (PCYC.O: Quote, Profile, Research Chief Executive Richard Miller on Wednesday expressed confidence that the company's experimental cancer vaccine will win U.S. approval despite initial rejection of the new drug application by U.S. health regulators. The tiny biotechnology company last month took the unusual step of filing its application for the vaccine Xcytrin over protest, in effect forcing the Food and Drug Administration to review it for approval despite the FDA refusal based on the drug's failure to meet a prespecified primary goal in a pivotal late stage clinical trial of patients with lung cancer that had spread to the brain. "I'm convinced we'll get Xcytrin approved eventually for something because I believe it's an active drug," Miller said in an interview. "I think our data shows substantial efficacy and I think if they review it in detail and put it in proper context, bringing in advisors who know the disease, that it should meet that standard" (for approval), Miller said. Reuters Pictures Editors Choice: Best pictures from the last 24 hours. View Slideshow With some 100,000 cases of brain metastases from lung cancer diagnosed in the United States each year, and few if any treatment options available that address the cognitive and physical impairments caused by the disease, Miller said Xcytrin could become a hugely successful product. "I believe it would become the standard of care," he said. "There's no other treatment, so why wouldn't a doctor use this? If people look at the data in detail, they'll want to use this drug." © Reuters 2007. All rights reserved Quote Link to comment Share on other sites More sharing options...
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