June 15, 2020
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FDA expands Gardasil 9 approval for head and neck cancer prevention

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The FDA expanded the indication of HPV 9-valent vaccine, recombinant to include prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, according to a manufacturer-issued press release.

HPV 9-valent vaccine, recombinant (Gardasil 9, Merck) is approved for use by females aged 9 to 45 years 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.

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

For males aged 9 to 45 years, the vaccine 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.

According to CDC data, HPV-related oropharyngeal cancer has surpassed cervical cancer as the most common type of cancer caused by HPV in the U.S.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than 2 decades,” Alain Luxembourg, MD, PhD, director of clinical research at Merck Research Laboratories, said in the press release. “[This] 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.”