Merck GARDASIL 9 Approved By The FDA For The Prevention Of Certain HPV-related Head And Neck Cancers

- Jun 24, 2020-

On June 13, Merck & Co. (MSD) announced that the US FDA has approved GARDASIL 9 for the prevention of oropharyngeal cancer and other head and neck caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58 Department of cancer. The accelerated approval of oropharyngeal and head and neck cancer indications is based on the effectiveness of preventing HPV-related anogenital diseases. Approval of this indication may depend on the verification and description of clinical benefit in confirmatory trials.

Dr. Alain luxemborg, Director of Clinical Research at Merck Research Laboratories, said: "For more than two decades, helping prevent certain HPV-related cancers has been a priority for Merck, and today GARDASIL 9 is approved for the prevention of HPV-related Oropharyngeal cancer and other head and neck cancers represent an important step in Merck’s mission to help reduce the number of people affected by certain HPV-related cancers."

GARDASIL 9 can be applied to women aged 9 to 45 years to prevent cervical cancer, vulvar cancer, vaginal cancer, oropharyngeal cancer, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; 6, 11, 16, 18, 31, 33, 45, 52, and 58 HPV-induced cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions; and genitalia caused by HPV types 6 and 11 Warts; GARDASIL 9 can also be applied to 9-45 year old men to prevent anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; by 6, 11, 16 , 18, 31, 33, 45, 52, and 58 HPV-induced anal precancerous lesions or dysplasia; and genital warts caused by HPV types 6 and 11.

About HPV and HPV-related cancers and diseases

Both men and women are at risk of developing HPV-related oropharyngeal cancer; however, this type of cancer affects men five times as much as women. Oropharyngeal cancer can be caused by HPV infection, including the soft palate, the lateral and posterior walls of the throat, tonsils, and the posterior third of the tongue. According to a model recently released by the US Centers for Disease Control and Prevention (CDC), HPV-induced oropharyngeal cancer has surpassed cervical cancer, becoming the most common type of HPV-related cancer in the United States. According to CDC data, an estimated 14 million new HPV infections occur in the United States each year. Human papillomavirus is so common that 80% of sexually active people are infected with human papillomavirus at some stage of their lives. For most people, the human papilloma virus will clear itself; but for those who cannot clear the virus, it may cause certain cancers and diseases. There is no way to know who has HPV will develop cancer or other health problems. GARDASIL 9 (nine-valent human papillomavirus vaccine, recombinant) helps protect against the 7 HPV types that cause most HPV-related cancers in the United States. Persistent HPV infection can also cause precancerous lesions and may require additional follow-up procedures. Except for cervical cancer, there is currently no routinely recommended screening method for detecting HPV-related cancers.

GARDASIL 9 dosage and administration

GARDASIL 9 should be injected intramuscularly in the deltoid or anterolateral area of the thigh. For individuals 9 to 14 years of age, GARDASIL 9 can be administered in 2 or 3 dose regimens. For a two-dose regimen, the second dose should be given 6-12 months after the first dose. If the second dose is less than 5 months after the first dose, the third dose should be at least 4 months after the second dose. For the three-dose regimen, GARDASIL 9 should be administered at 0, 2 and 6 months; for individuals 15 to 45 years old, GARDASIL 9 should be administered 3 times at 0, 2 and 6 months Dosing regimen.