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

The oropharyngeal and head and neck cancer indication is approved under the agency’s accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, which is currently underway.

An estimated 14 million new HPV infections occur every year in the United States, according to the CDC. HPV is so common that 80% of people who are sexually active get HPV at some point in their life. For most people, HPV clears on its own; however, for those who don’t clear the virus, it could cause certain cancers and diseases. There is no way to predict which people who have HPV will develop cancer or other health problems. 

Both men and women can be at risk for HPV-related oropharyngeal cancer, but this cancer occurs five times more commonly in men. According to a recent model published by the CDC, HPV-related oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the United States.
Gardasil 9  helps protect against seven HPV types that cause most HPV-related cancers in the United States. Persistent HPV infection can also lead to precancerous lesions that may require additional follow-up procedures. With the exception of cervical cancer, there is no routinely recommended screening for the detection of HPV-related cancers.

Gardasil 9 vaccine is indicated for females aged 9 through 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.

Gardasil 9 is indicated for males aged 9 through 45 years 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.

The HPV vaccine is contraindicated in individuals 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].

For individuals aged 15 through 45 years, Gardasil 9 is administered using a three-dose schedule at 0, 2 months and 6 months.

—Clinical Oncology News Staff

Based on a press release from Merck.