An FDA panel has recommended expanding the indications for Merck & Co.’s human papillomavirus (HPV) vaccine Gardasil to include the prevention of anal cancer. The endorsement comes after a clinical trial that followed 4,065 men, 602 of them gay, for 36 months. At the trial’s conclusion, 3 percent of the gay men who received the vaccine had developed anal cancer or anal lesions, compared to 12 percent of the men who got a placebo. The FDA is expected to rule on whether to follow the panel’s recommendation by the end of the year; it probably will also rule on whether to expand Gardasil’s indication to include preventing cervical cancer in women 27 to 45. Anal cancer is relatively uncommon, striking about 5,000 Americans each year, with about 90 percent of cases thought to be caused by HPV.
Dr. Ross says that if Gardasil and GlaxoSmithKline’s competing HPV vaccine Cervarix “were more widely accepted, we could eradicate cervical and anal cancer — and markedly reduce the incidence of HPV-associated oral and pharyngeal cancer.”
Dr. Whelan says she’s still impressed by the idea of a vaccine that prevents cancer. “I think it’s just fantastic.”