Accelerated FDA approval for new use of Gardasil 9

13 June 2020

Under the agency’s accelerated review scheme, the US Food and Drug Administration on Friday approved an expanded indication for Gardasil 9 (human papillomavirus 9-valent 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 based on effectiveness of the vaccine 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, says the vaccine’s marketer, US pharma giant Merck & Co (NYSE: MRK).

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