Merck's GARDASIL Vaccine Receives FDA Panel's Recommendation for Anal Cancer Prevention

Strategic Insights -

The US Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented by Merck support an indication for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age. The Committee's input will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in early 2010. GARDASIL has been approved in the US for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, and vaginal cancers, as well as genital warts.

Key Takeaways:

  • GARDASIL has shown efficacy in preventing HPV-related anal disease in men who have sex with men, a population at high risk of anal infection and disease.
  • Up to 90 percent of anal cancers are caused by HPV, with HPV types 16 and 18 causing approximately 80 percent of those cases.
  • The FDA is considering Merck's supplemental Biologics License Application (sBLA) for GARDASIL for the prevention of anal cancer and AIN in both males and females 9 through 26 years of age.
  • GARDASIL has been approved for use in boys and men ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.
  • The vaccine does not eliminate the necessity for women to continue undergoing recommended cervical cancer screening.

Statistics:

  • Up to 90 percent of anal cancers are caused by HPV (Source: Merck, 2010)
  • HPV types 16 and 18 cause approximately 80 percent of anal cancer cases (Source: Merck, 2010)
  • HPV types 6 and 11 account for approximately 90 percent of genital warts cases (Source: Merck, 2010)
  • HPV types 16 and 18 account for approximately 75 percent of cervical cancer cases (Source: Merck, 2010)
  • GARDASIL protects against HPV types 6, 11, 16, and 18, which cause approximately 90 percent of genital warts and 75 percent of cervical cancer cases (Source: Merck, 2010)

Sources:

  • Merck (2010)
  • US Food and Drug Administration (FDA)
  • NewsRx.com