FDA Approves Gardasil 9 for Prevention of Oropharyngeal, Head & Neck Cancers Caused by HPV

June 15, 2020

The FDA approved an expanded indication for the HPV 9-valent vaccine, recombinant for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

The FDA has approved an expanded indication for the human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9) for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58, according to Merck, the agent’s developer.

The oropharyngeal and head and neck cancer indication was approved under accelerated approval based on the effectiveness Gardasil 9 has demonstrated in preventing HPV-related anogenital disease. However, continued approval for this indication may be dependent upon verification and description of clinical benefit in a confirmatory trial, which is currently underway.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than two decades,” Alain Luxembourg, MD, PhD director of clinical research at Merck Research Laboratories, said in a press release. “Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents an important step in Merck’s mission to help reduce the number of men and women affected by certain HPV-related cancers.”

The vaccine is indicated in females 9 years of age through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.

In males 9 years of age through 45 years of age, Gardasil 9 is indicated for the prevention of anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.

Moreover, Gardasil 9 is contraindicated for individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or HPV Quadrivalent (types 6,11, 16, and 18) vaccine, recombinant (Gardasil).

Notably, the CDC analyzed data from the US Cancer Statistics (USCS) to assess the incidence of HPV-associated cancers and to estimate the annual number of cancers caused by HPV, overall and by state, during 2012 to 2016. According to a model recently published by the organization, HPV-attributable oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the US.

Reference:

FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers [news release]. Kenilworth, NJ. Published June 12, 2020. mrknewsroom.com/newsroom/news-releases/news-details/2020/FDA-Approves-Mercks-GARDASIL-9-for-the-Prevention-of-Certain-HPV-Related-Head-and-Neck-Cancers/default.aspx. Accessed June 15, 2020.