Archive for Friday, May 19, 2006

Cervical cancer shot shows early promise

FDA panel recommends vaccine’s approval

May 19, 2006

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— A vaccine with the potential to slash worldwide deaths from cervical cancer, the No. 2 cancer killer in women, should be approved for sales in the United States, a federal panel said Thursday.

A Food and Drug Administration advisory committee voted 13-0 to endorse the safety and effectiveness of Merck and Co.'s Gardasil, which blocks viruses that cause cervical cancer. The company said the vaccine could cut worldwide deaths from the disease by two-thirds.

However, the anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500 - a possible impediment to widespread vaccination campaigns.

The drug protects against the two types of human papillomavirus, or HPV, believed responsible for about 70 percent of cervical cancer cases. It also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.

The FDA is not required to follow the recommendations of its outside panels of experts but usually does. An agency decision is expected by June 8.

HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills about 290,000 women worldwide each year, including 3,500 in the United States where regular Pap smears often detect precancerous lesions and early cancer.

"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Dr. Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine in Atlanta.

Early opposition to Gardasil was based on concerns it could encourage sexual activity in preteens and teens. But that largely faded away because of the vaccine's potential for reducing cancer.

Making their case for approval, Merck officials suggested that Gardasil could be the biggest advance in preventing cervical cancer since the Pap test.

"Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer," Merck's Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.

Several speakers said the vaccine should not replace screening. Merck said the vaccine was not intended to do that but that it could eliminate many of the abnormalities the tests turn up.

"We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to health care providers and patients the continued need for regular cervical screening," said Amy Allina, program director of the National Women's Health Network.

Merck said the vaccine could be used in females age 9 to 26 but would work best when given to girls before they begin having sex.

The company is seeking to license Gardasil in more than 50 countries, said Dr. Eliav Barr, who headed the vaccine program at Merck.

Pending action by the FDA, the national Advisory Committee on Immunization Practices will decide in June whether to endorse routine vaccination with the vaccine.

The committee's HPV vaccine group is recommending giving the vaccine to girls who are 11 and 12 years old. The 15-member committee of experts who advise the government will consider recommendations for females 13 to 26. Merck seeks use of the vaccine in girls as young as 9.

Analysts think Gardasil sales could top $1 billion a year for Merck, which is battling thousands of lawsuits over its withdrawn painkiller Vioxx.

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