FDA approves Gardasil-9 for prevention of head and neck cancers

  • Merck & Co., Inc.
  • 12 Jun 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • The US Food and Drug Administration (FDA) has expanded the indication for HPV 9-valent vaccine, recombinant (Gardasil-9) to include prevention of oropharyngeal and other cancers of head and neck caused by HPV types 16, 18, 31, 33, 45, 52, and 58.

Key points

  • The expanded indication approved under the FDA's accelerated approval program is based on the vaccine's efficacy in preventing HPV-related anogenital disease.
  • HPV has been established as the causative agent for most oropharyngeal squamous cell cancers diagnosed in the United States.
  • A study published in 2019 found that the frequency of oral HPV infections was lower among sexually active female adolescents who had received the quadrivalent vaccine than among unvaccinated individuals.
  • The findings suggested that vaccination could lower the future risk for HPV-associated head and neck cancers.
  • Individuals at risk for exposure to a new HPV infection from a new sex partner are most likely to benefit from HPV vaccination.
  • Approval of the expanded indication is contingent on confirmatory data awaited from an ongoing phase 3 multicenter randomized trial in men ages 20-45 years.

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