FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases
On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9). The application is seeking approval for an expanded age indication—ie, in women and men aged 27 to 45 years—for the prevention of certain cancers and diseases caused by the 9 HPV types covered by the vaccine. The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act date of October 6, 2018.
About the Vaccine
The HPV 9-valent vaccine is indicated in the United States in females aged 9 to 26 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11. The 9-valent vaccine is also indicated in males aged 9 to 26 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.
After HPV types 16 and 18, the five additional HPV types in the 9-valent vaccine are the most common cervical cancer–causing types worldwide. Seven HPV types in the vaccine (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as cervical intraepithelial neoplasia [CIN] 2, CIN 3, and adenocarcinoma in situ) worldwide. These seven HPV types also cause 90% of HPV-related vulvar cancers, 85% of HPV-related vaginal cancers, and 90% of HPV-related anal cancers. HPV types 6 and 11 cause approximately 90% of genital warts cases. In addition, approximately 50% of cases of low-grade cervical lesions (CIN 1) are caused by the nine HPV types included in the vaccine.
The HPV 9-valent vaccine is approved for use in more than 70 countries.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
