Cervical Cancer Vaccine Delayed

Merck & Co. has hit a bump in the road in its plans to expand the label for its cervical cancer vaccine Gardasil^®. The company announced yesterday that it received letters from the US Food and Drug Administration(FDA) for two supplemental biologic license agreements for use in women ages 27 to 45.

Merck said it has already discussed with the FDA questions pertaining to use of the drug in treating older women, and plans to respond to the letters, which cite “issues” with the drug. As far as cross-protection is concerned, the FDA has indicated that the data submitted do not support treatment in those with non-vaccine human papillomavirus (HPV) and may be dropping plans for expansion altogether.

Gardasil was first approved in 2006 for women and girls ages 9 to 26 to prevent cervical cancer, cervical pre-cancers, vulvar pre-cancers and vaginal pre-cancers caused by HPV types 16 and 18, as well as genital warts and low-grade lesions caused by HPV types 6, 11, 16 and 18, according to The Pink Sheet DAILY. The drug has achieved positive results within its first year on the market, but Merck continues to looking for ways to expand their reach, including indications in boys and men ages 9 through 26.

As the world’s first vaccine in the prevention of cervical cancer, Gardasil is concerned about long-term plans for the drug, following recent setbacks, and hopes to establish future plans come July. According to a spokesperson for the drugs, the most important new opportunity for the vaccine will be for its use in males and could aid in the prevention of HPV and the spread to females through sexual contact.

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Additional Resources:

Cervical Cancer Vaccine: Who Needs it and How it Works

Cervical Cancer Vaccine to be Given in Schools by September

HIQA Backs Cervical Cancer Vaccine for Young Girls

HPV Vaccines for Cervical Cancer