MSD’s GARDASIL 9 approved for head and neck cancers

Pharma News: Merck, known as MSD outside the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approval of an expanded indication for GARDASIL 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV genotypes 16, 18, 31, 33, 45, 52, and 58.

HPV is estimated to cause more than 90 percent of anal and cervical cancers, around 70 percent of vaginal cancers, and 60 percent of penile cancers. Previously, oropharyngeal cancers were largely thought to be caused by tobacco and alcohol use, but based on recent studies, experts believe as much as 70 percent of head and neck cancers may be due to HPV infections.

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

In February, Merck launched a 6,000-patient study to evaluate the efficacy and safety of its vaccine to prevent oral HPV infection in men between 20 and 45 years of age. HPV-related oropharyngeal cancers, which occur at the back of the throat and often involves the base of the tongue and tonsils, affect men five times more than women. 

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.

In Australia, GARDASIL 9 is indicated in females aged 9 to 45 years for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52 and 58. In males 9 to 26 years of age it is indicated for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.