MSD has bagged US approval for an expanded indication for Gardasil for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
The indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease, the firm noted, adding that continued approval in this setting could be contingent on verification of clinical benefit in a confirmatory trial (which is currently underway).
While both sexes can develop HPV-attributable oropharyngeal cancer, it affects men five times more than women.
The disease can arise as a result of HPV infection in the oropharynx, which includes the soft palate, side and back wall of the throat, tonsils, and back one-third of the tongue, and according to a recent model published by the US Centers for Disease Control and Prevention (CDC), it has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the country.
Gardasil is already approved to prevent in women cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers, as well as genital warts and anal precancerous or dysplastic lesions, caused by human papillomavirus (HPV).
In men, the vaccine is indicated for prevention of anal, oropharyngeal and other head and neck cancers, as well as genital warts and anal precancerous or dysplastic lesions, caused by HPV.