Advisory Panel For Bristol's Yervoy Is Called Off, Which May Bode Well
This article was originally published in The Pink Sheet Daily
Executive Summary
After extending the review, FDA says it no longer needs ODAC's advice on the second-line melanoma treatment, which looks like a good sign for approval.
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After postponing it once, FDA has now cancelled a planned Oncologic Drugs Advisory Committee review of Bristol-Myers Squibb's second-line melanoma treatment Yervoy (ipilimumab), saying it no longer needs the panel's advice - which looks like a positive signal for the drug's eventual approval. "The issues for which FDA was seeking the scientific input of the committee have been resolved," the agency said in announcing the cancellation of the meeting, which had been planned for Feb. 9. FDA previously postponed the ODAC meeting from Dec. 2 to Feb. 9 after moving the Prescription Drug User Fee Act review date for the anti-CTLA-4 monoclonal antibody from Dec. 25 to March 26, 2011 (Also see "Bristol's Yervoy Gets A Bigger Advisory Committee Cushion" - Pink Sheet, 8 Dec, 2010.). The company explained the delay by saying that FDA had asked it for an additional data analysis that the agency considered a major amendment to the drug's BLA, which the company had filed in July. Bristol submitted the requested analysis, and noted that "it's not uncommon for the agency to ask additional questions as part of the review process for a new drug application, particularly when the drug has a novel mechanism of action." The fact that FDA no longer needs ODAC to weigh in seems a signal that the agency is now satisfied with the analysis. "The need for an ODAC is determined by the FDA," the company said in an e-mail. "Bristol-Myers Squibb continues to be encouraged by the ongoing collaborative review of the application with the agency and looks forward to addressing an important unmet medical need for patients with advanced melanoma. The FDA action date remains March 26, 2011." The cancellation also is noteworthy because FDA is required to bring all new molecular entities and novel biologics to an advisory committee review unless it can document why a meeting would be unnecessary (Also see "Increased Advisory Cmte. Preparation Ahead May Challenge FDA, Sponsors" - Pink Sheet, 26 May, 2008.). Not Always A Good Sign However, advisory committee cancellations do not always bode well for a drug's approval. For example, the agency announced at the last minute that it was cancelling a June 28 meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee that was set to review Lux Biosciences and Isotechnika's drug Luveniq (voclosporin) to treat uveitis (Also see "Last-Minute Cancellation Of Advisory Panel Meeting Throws Future of Luveniq Into Doubt" - Pink Sheet, 23 Jun, 2010.). This was followed shortly thereafter by a "complete response" letter in which the agency said an additional clinical trial would be needed for approval (Also see "FDA Says Lux's Uveitis Treatment Luveniq Needs Another Clinical Trial" - Pink Sheet, 4 Aug, 2010.). More recently, FDA canceled a Dec. 2 advisory committee review of Endo Pharmaceuticals' tamper-resistant, extended-release oxymorphone because "the agency believes the information received from previous advisory committee meetings is adequate to allow the agency to address the specific concerns in the application," a Nov. 19 Federal Register notice stated (Also see "Regulatory And Policy News, In Brief" - Pink Sheet, 22 Nov, 2010.). The PDUFA date for that drug is Jan. 7. -Martin Berman-Gorvine ( [email protected] ) |