Gardasil 9, the latest version of the well-known human papillomavirus virus vaccine, has been approved by the Food and Drug Administration (FDA) for the prevention of HPV related throat and neck cancers. The FDA gave the drug an accelerated approval, which means their decision is dependent on more information. Merck started a study to see if Gardisil treats these cancers in February.
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.
Merck Press Release
The trial is focused on men after researchers noticed that certain throat cancers linked to HPV were most common in middle-aged men who had contracted the virus decades earlier. Other throat cancer risks include smoking cigarettes and performing oral sex on partners with HPV.
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Introduced in 2006, Gardisil was marketed to young women and girls aged 9 to 26. Those recommendations expanded to include men and to the age of 45 in 2018 with the introduction of Gardisil 9. Demand for Gardisil has continued to increase worldwide since its introduction, with total vaccine sales reaching 3.15 billion in 2018.
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Sources:
- FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer – Statnews
- FDA Approves HPV Vaccine to Prevent Throat Cancer – Labroots
- Unprecedented global demand for Gardasil 9 – Pharmaceutical Technology