FDA approves HPV vaccine for anal cancer

The FDA announced today that it has approved Gardasil as a vaccine for anal cancer and associated precancerous lesions related to human papillomavirus types 6, 11, 16 and 18.

The new indication is for patients aged 9 through 26 years. Gardasil (Merck) is already approved for the same age population for the prevention of cervical, vulvar and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in women and girls, and for the prevention of genital warts caused by types 6 and 11 in both males and females

The FDA’s Vaccines and Related Biological Products Advisory Committee recommended extending the indication for Gardasil earlier this month.

Anal cancer is relatively rare, representing approximately 4% of all lower gastrointestinal tract cancers diagnosed in the US, but incidence is increasing and 90% of cases are related to HPV. The American Cancer Society estimates that about 5,300 Americans are diagnosed with anal cancer annually. Men who have sex with men (MSM) are at greatest risk, but women make up 60% of diagnoses.

“Treatment for anal cancer is challenging,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure.”

Approval for the new indication is based on a single randomized, controlled trial of 4,065 patients, including 602 men who have sex with men. Among the MSM population, the point estimate of efficacy for Gardasil was 78% (95% CI, 40-93) for the primary composite endpoint of prevention of any grade anal intraepithelial neoplasia and anal cancer. Efficacy was 75% (95% CI, 9-93) for grade 2 or higher anal intraepithelial neoplasia.

There were no cases of invasive anal cancer in the study.

Overall efficacy was 50% (95% CI, 26-27) for any grade anal intraepithelial neoplasia and anal cancer. For grade 2 or higher anal intraepithelial neoplasia, efficacy was 54% (95% CI, 18-75).

Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.

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