FDA Approves Merck’s GARDASIL 9 for Prevention of Certain HPV-Related Head and Neck Cancers
Jun 14, 2020 16:02
CST Updated
Jun 13, 16:59
MSD
Pharmaceutical R&D and Manufacturer
June 13, 2020 /BioValleyBIOON/ -- Merck & Co. recently announced that the U.S. Food and Drug Administration (FDA) has approved the expanded indication for the HPV vaccine Gardasil 9 (9-valent), for the prevention of oropharyngeal cancer and other head and neck cancers caused by seven high-risk HPV types (16, 18, 31, 33, 45, 52, 58). This indication for oropharyngeal and head and neck cancers is accelerated approval based on the effectiveness of Gardasil 9 in preventing HPV-related anogenital diseases. Continued approval for this indication may depend on the verification and description of clinical benefits in confirmatory trials, which are currently ongoing.
Dr. Alain Luxembourg, Director of Clinical Research at MSD Research Laboratories, stated: “At MSD, helping to prevent certain HPV-related cancers has been a priority for more than 20 years. Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents a significant step forward in MSD’s mission to help reduce the number of men and women affected by certain HPV-related cancers.”
Gardasil 9 is a human papillomavirus (HPV) vaccine indicated for females aged 9–45 years: (1) for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by seven high-risk HPV types (16, 18, 31, 33, 45, 52, 58); (2) for the prevention of precancerous or dysplastic lesions of the cervix, vulva, vagina, and anus caused by nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, 58); (3) for the prevention of genital warts caused by two low-risk HPV types (6, 11).
Gardasil 9 is indicated for males aged 9–45 years: (1) for the prevention of anal, oropharyngeal, and other head and neck cancers caused by seven high-risk HPV types (16, 18, 31, 33, 45, 52, 58); (2) for the prevention of anal precancerous or dysplastic lesions caused by nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, 58); and (3) for the prevention of genital warts caused by two low-risk HPV types (6, 11).
In 2019, global sales of MSD’s Gardasil (Gardasil/Gardasil 9) reached $3.737 billion, representing a 19% increase from the previous year.
Both men and women can develop HPV-related oropharyngeal cancer; however, this cancer affects men five times more often than women. For most people, HPV clears on its own. However, in those who do not clear the virus, it can lead to certain cancers. Oropharyngeal cancer may be caused by HPV infection of the oropharynx, which includes the soft palate, the lateral and posterior walls of the throat, the tonsils, and the posterior one-third of the tongue.
According to a recently released model by the U.S. Centers for Disease Control and Prevention (CDC), HPV-associated oropharyngeal cancer has surpassed cervical cancer to become the most common HPV-related cancer in the United States.(Bioon.com)