FDA expands approval for Gardasil 9 to include oropharyngeal and other head and neck cancers.- Meck Inc

Merck Inc announced that the FDA has approved an expanded indication for GARDASIL 9 vaccine for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under 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. The trial is currently underway. Comment: Both men and women can be at risk for HPV-attributable oropharyngeal cancer; however, this cancer affects men five times more than women. For most people, HPV clears on its own. But, for those who don't clear the virus, it can cause certain cancers. Oropharyngeal cancer 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. According to a recent model published by the U.S. Centers for Disease Control and Prevention, HPV-attributable oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the U.S.