FDA Approves Gardasil 9 for Expanded Indication in Certain HPV-Related Head and Neck Cancers

The FDA has granted approval to an expanded indication for Gardasil 9 (human papillomavirus [HPV] 9-valent vaccine, recombinant, Merck), for the prevention of oropharyngeal cancer and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

The oropharyngeal and head and neck cancer indication was granted accelerated approval based on Gardasil 9’s efficacy in preventing HPV-related anogenital disease, according to a press release. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial that is currently underway.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than two decades,” said Alain Luxembourg, MD, PhD, director, clinical research, Merck Research Laboratories. “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.”

Oropharyngeal cancer can result from HPV infection in the oropharynx, including the soft palate, side and back wall of the throat, tonsils, and back one-third of the tongue.

Gardasil 9 is a vaccine indicated in females from 9 through 45 years of age to prevent 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.

For males 9 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.

Gardasil 9 is contraindicated in those with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil (HPV quadrivalent [types 6, 11, 16, and 18] vaccine, recombinant).

Reference

FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers. News release. Merck; June 12, 2020. Accessed June 15, 2020. https://www.businesswire.com/news/home/20200612005599/en/FDA-Approves-Merck%E2%80%99s-GARDASIL-9-Prevention-HPV-Related