FDA Approves Cervical Cancer Vaccine

ROCKVILLE, Md. June 8 - The FDA today approved Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18] recombinant vaccine) for prevention of cervical cancer and for prevention of cervical, vulvar and vaginal pre-cancers caused by HPV types 16 and 18.

The agency said the vaccine, made by Merck, was approved for immunization of girls and women ages nine to 26. The vaccine was not approved for immunization of boys, however, a blow to the cancer prevention community that had campaigned for approval in both boys and girls.

Nonetheless, the approval marked the first time the FDA has approved a vaccine to prevent cancer.

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs.

Earlier this week Robert F. Ozols, M.D., Ph.D., senior vice president of the medical science division at Fox Chase Cancer Center in Philadelphia, said widespread use of the vaccine could be "a transforming event that could wipe out cervical cancer."

In phase III trials submitted to the FDA:

• Gardasil prevented 100% of HPV-16 and 18-related cervical pre-cancers and non invasive cervical cancers (CIN 2/3 and adenocarcinoma in situ [AIS]);
• Gardasil prevented 95% of low grade cervical dysplasia and AIS caused by HPV 6, 11, 16 or 18;
• Gardasil prevent 99% of genital warts caused by HPV 6 or 11.

An advisory committee has also recommended approval of the vaccine for prevention of genital warts and other genital lesions caused by HPV types 6, 11, 16, and 18.

Gardasil is administered in a three separate intramuscular injections. Merck said the catalogue price will be per dose.

"HPV is the most common sexually-transmitted infection in the United States. The CDC estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives.

On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women; and is estimated to cause over 470,000 new cases and 233,000 deaths each year.

Related Articles:

• AACR: Investigational Vaccines Aim at Broad Range of HPV Types
• FDA Advisers Give Nod to Cervical Cancer Vaccine
• IDSA: HPV Vaccine Gets High Marks in Trial
• ICAAC: Investigational HPV Vaccine Prevents Genital Warts and Cancers
• ASCO: Cervical Cancer Vaccine Also Protective for Vaginal and Vulvar Lesions