FDA panel
unanimously backs cervical cancer vaccine

A Merck vaccine that blocks a sexually transmitted virus that causes cervical cancer moved closer to the market on Thursday as U.S. advisers unanimously said it was safe and effective for women and girls as young as age 9.

The vaccine, Gardasil, could offer a major boost to women's health and the struggling drugmaker's fortunes. Some analysts predict annual sales topping $2 billion.

Gardasil targets common types of the sexually transmitted human papillomavirus, or HPV, which causes genital warts and skin warts and most cervical cancer cases. Cervical cancer is an AIDS-defining condition among HIV-positive women.

Members of a Food and Drug Administration advisory panel said they were persuaded by Merck's data showing Gardasil prevented early-stage cervical cancer and precancerous lesions. Several cautioned, however, that the vaccine worked only against four HPV types and that women would still need regular screening for the disease.

"It's not going to get rid of all cervical cancer. There are other HPV types that cause cancer," said Monica Farley, the panel's chairwoman.

A final FDA decision is expected by June 8, putting Merck ahead of a potential rival vaccine in development by GlaxoSmithKline.

Merck and France's Sanofi-Aventis would market Gardasil through a joint venture in Europe, if the drug wins clearance there. (Reuters)