FDA Expands Gardasil 9 Approval for HPV-Related Cancers

On Friday, the FDA expanded the approval for Gardasil 9 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, according to Merck, the manufacturer of the vaccine.

According to the CDC, the majority (80%) of sexually active adults in the United States contract HPV within their lifetime. For most people, the virus clears up on its own, but for others, it can become cancerous — making vaccines like Gardasil 9 important.

While both men and women can contract HPV-related oropharyngeal cancer, the disease affects men 5 times more than women. Oropharyngeal cancer — the most prevalent type of HPV-related cancer in the United States – can be caused by an HPV infection in the oropharynx, which includes the soft palate, side and back wall of the throat, tonsils, and back third of the tongue.

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

Gardasil 9 is already approved to prevent HPV-related cervical, vulvar, vaginal, and anal cancers, as well as dysplastic lesions and genital warts in females between the ages of 9 and 45. It is also approved for males between the ages of 9 and 45 to prevent HPV-related anal cancer or dysplastic lesions and genital warts.

Most common adverse events (AEs) in females (occurring in 10% or more of patients) were injection-site pain, swelling, erythema, and headache. For males, common AEs were injection-site pain, swelling, and erythema.

“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,” Luxembourg said.