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Merck's cancer vaccine secures US FDA priority review for extended use

The U.S. Food and Drug Administration granted priority review to Merck & Co. Inc.'s application for human papillomavirus vaccine Gardasil 9 for preventing certain cancers and diseases in men and women ages 27 to 45.

The Kenilworth, N.J.-based company said its biologics license application is seeking approval for Gardasil 9 for preventing certain cancers and diseases caused by the nine human papillomavirus, or HPV, types covered by the vaccine.

Merck said the the U.S. regulator will take a decision on the application by October 6.

Gardasil 9, which had sales of about $660 million in the first quarter of 2018, is approved in the U.S. for females ages 9 to 26 years to prevent cervical, vulvar, vaginal and anal cancers and for males ages 9 to 26 to prevent anal cancer caused by certain HPV types.