By: Emily P. Walker
15 November 2010
WASHINGTON — Merck’s quadrivalent human papillomavirus recombinant vaccine, Gardasil, appears safe and effective at preventing anal cancer in males and females ages 9 to 26, FDA reviewers said.
The vaccine was approved in 2006 to treat genital warts and cervical, vulvar, and vaginal cancer in females ages 9 to 26; the vaccine’s indication was expanded in 2009 to include prevention of genital warts in males of that age.
Now, Merck is looking to expand the indication for its vaccine to prevent anal intraepithelial neoplasia and anal cancer caused by HPV strains 6, 11, 16, and 18 among males and females ages 9 to 26.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet Wednesday to discuss whether to expand Gardasil’s indication to include anal cancer. If it agrees with the FDA reviewers who recently released their assessment, then the panel will easily endorse the new indication.
The FDA does not have to follow the advice of its advisory committees, but it often does.
In their review of Merck’s new trial data, reviewers from the FDA’s Center for Biologics Evaluation and Research analyzed a new phase III double-blind, placebo-controlled study in which male subjects were randomized 1:1 to receive a three-dose regimen of Gardasil or aluminum adjuvant-containing saline.
The trial enrolled 4,065 males, of whom 602 were men who have sex with men (MSM) and are considered to be at a higher risk for anal cancer.
The data in the FDA’s review focused almost exclusively on the MSM data.
Read the entire article here.
(Note from SaneVax: Ostensibly, the CDC will base its recommendation on whether or not to recommend mass vaccination on the outcome of the FDA meeting tomorrow. How can any recommendation for use be based primarily on the study of 602 subjects?)