By: Sue Sutter
16 November 2010
A clinical reviewer for the Food and Drug Administration Center for Biologics Evaluation and Research sees no problem with using an anal dysplasia end point, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer.
Nevertheless, the agency is asking an advisory committee for input on these very issues at a Nov. 17 meeting, and a later review by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices panel may be key for utilization and reimbursement.
In his clinical review, medical officer Dr. Jeffrey Roberts of the Center for Biologics Evaluation and Research (CBER) said available data support approval of Gardasil for males and females aged 9-26 years, to prevent anal intraepithelial neoplasia (AIN) and anal cancer caused by human papillomavirus types 6, 11, 16, and 18, according to a briefing document for the meeting, which was posted by the FDA more than 2 weeks earlier than usual.
The session will mark the third time the FDA’s vaccines advisory committee has reviewed Merck’s quadrivalent HPV vaccine. To date, each meeting has amounted to a slam dunk for the company, and the FDA’s briefing documents on the anal cancer indication suggest Gardasil’s third trip before the committee is unlikely to be much different.
While a Gardasil anal cancer indication appears headed for a committee endorsement and FDA approval, a less certain question is whether the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) will find the data persuasive enough to recommend routine vaccination of males. ACIP’s deliberations are important to Merck for purposes of securing widespread use and reimbursement of Gardasil in boys and men.
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