Posted by Michael Wonder on 13 Jun 2020
FDA approves Merck’s Gardasil 9 for the prevention of certain HPV related head and neck cancers
12 June 2020 - Gardasil (human papillomavirus 9 valent vaccine, recombinant) now approved for the prevention of HPV related cervical, vaginal, vulvar, anal, oropharyngeal and other head and neck cancers.
Merck today announced that the U.S. FDA has approved an expanded indication for Gardasil 9 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.
