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.
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.”
Perspective
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Saral Mehra, MD, MBA, FACS
Oropharyngeal cancer has surpassed cervical cancer in terms of HPV-related cancer incidence, and there is no effective screening for oropharynx cancer. We have only two ways to attempt to limit the impact of HPV-related oropharynx cancer in this country: awareness and vaccination. The FDA approval of HPV 9-valent vaccine, recombinant specifically for the prevention of head and neck cancer hopefully will help increase vaccination rates across the country, which are remarkably low compared with other vaccines. Although the new FDA indication should help, increased patient, parent and physician education and awareness will be crucial for this to have a long-term impact.
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