Human Papillomavirus 9-valent Vaccine Gardasil 9 Approval for the Prevention of Cervical, Vulvar, Vaginal,, Anal Cancer, Genital Warts, etc.

By GCS (LinkedIn and Twitter)

0214-FDA approves Gardasil9

FDA has approved Gardasil 9, which is a recombinant vaccine for human papillomavirus 9-valent vaccine.

Gardasil 9 is indicated for the prevention of the following:

For females aged 9 to 26 years of age:

  • Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
  • The following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
  • Cervical intraepithelial neoplasia (CIN) grade 1, 2 and 3 and cervical adenocarcinoma in situ (AIS).
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and 3.
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and 3. Anal intraepithelial neoplasia (AIN) grades 1, 2 and 3.

For males aged 9 to 15 years of age:

  • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11.
  • AIN grades 1, 2 and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

Download FDA Approval Letter

Download “FDA Approval Letter” UCM428239.pdf – Downloaded 251 times – 136 kB

 

Background Information for HPV Infections

HPV infections cause benign and malignant dysplastic diseases, localized primarily in the anogenital area, in both men and women. Chronic HPV infection significantly increases the risk of cervical and other anogenital cancers.

Cervical cancer is the second most common cancer in women worldwide, associated with approximately 530,000 incident cases and 275,000 deaths each year.

Overall, HPV is responsible for approximately 5% of the global cancer burden. Nearly 100% of cervical cancers and 90% of anal cancers are caused by oncogenic HPV types.

Approximately 70% of cervical cancers and 90% of anal cancers are caused by HPV types 16 and 18, both of which are targeted by the currently licensed HPV vaccines, GARDASIL (quadrivalent; HPV types 6, 11, 16, and 18) and Cervarix (bivalent; HPV types 16 and 18). However, both GARDASIL and Cervarix do not provide effective cross-protection against other oncogenic HPV types.

There is an unmet medical need for a vaccine that prevents anogenital cancers caused by HPV types other than HPV 16 and 18. GARDASIL 9 targets five additional oncogenic HPV types (31, 33, 45, 52, and 58) that together cause approximately 20% of cervical cancers. Thus, GARDASIL 9 has an estimated potential to prevent 90% of anogenital cancers caused by HPV.

Data to support this BLA were generated in studies conducted under IND 13447 (established in August 2007). At the End-of-Phase 2 Meeting (September 2008), CBER agreed that the labeled indication for GARDASIL 9 would be based on (1) demonstration of clinical efficacy against persistent infection and a composite disease endpoint caused by the five new HPV types (31, 33,45, 52, and 58), and (2) non-inferior immunogenicity for the four original HPV types (6, 11, 16, and 18).

Last Date Updated on December 29, 2014

FDA Approves GARDASIL 9 Vaccine for Human Papillomavirus 9
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