Merck’s
cervical cancer vaccine gets priority review

Drugmaker Merck has announced that the Food and Drug Administration has given its Gardasil cervical cancer vaccine priority review status that will produce a decision on the treatment by June.

Gardasil is an investigational cervical cancer vaccine designed to protect against two types of viruses that account for an estimated 70% of cervical cancer cases and two types of viruses that account for an estimated 90% of genital wart cases in both men and women.

A priority review means the agency will rule on a given drug application in six months, rather than the standard 10 months. The FDA told the company it will rule on the application by June 8.

Since Merck submitted the application to the FDA in December, it has also submitted marketing applications for Gardasil in Europe, Australia, Mexico, Brazil, Argentina, Taiwan, and Singapore.

Cervical cancer has been linked to infection with the sexually transmitted human papillomavirus, which also can cause genital and anal warts in women and men. Cervical cancer also is an AIDS-defining condition among HIV-positive women. (AP, with additional reporting by Advocate.com)