Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?
A Center for Biologics Evaluation and Research clinical reviewer sees no problem with using an anal dysplasia endpoint, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer.
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Expanded indication does not actually expand the target population for the HPV vaccine, but the data should bolster Merck's argument for a routine vaccination recommendation in males when it goes before CDC's Advisory Committee on Immunization Practices.
Most members of the Vaccines and Related Biological Products Advisory Committee agreed that similarities in the disease across genders supported extrapolating male-only study data on the HPV vaccine to females.
Supplemental application filed earlier this year is part of Merck's strategy to broaden use of the HPV vaccine, although its bid to expand the label to women ages 27-45 has thus far been blocked by the agency.