FDA Panel Supports Extending Gardasil Label to Anal Cancer

An FDA advisory panel has supported Merck’s Gardasil vaccine to prevent anal cancer and anal intraepithelial neoplasia in both males and females age 9 to 26. The Vaccines and Related Biological Products Advisory Committee overwhelmingly agreed that the data are strong enough to support the additional indication, FDA spokeswoman Shelly Burgess said. Merck expects an FDA decision on the indication by the end of the year, according to company spokeswoman Pamela Eisele.
Washington Drug Letter