Looks like Gardasil is likely to be approved...
Surprising MRK estimates of Cerical Cancer - 9,000 in the USA yet almost 300,000 worldwide.
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FDA Finds Merck Vaccine Effective
In Preventing Cervical Cancer
By JENNIFER CORBETT DOOREN
May 17, 2006 12:03 p.m.
WASHINGTON -- The Food and Drug Administration said Wednesday that a proposed Merck & Co. vaccine designed to protect against cervical cancer in women was safe and effective.
The FDA made its comments in documents posted to its Web site ahead of a Thursday meeting of an outside panel of medical experts. The FDA routinely calls on expert advisory panels to make recommendations about whether various products should be approved, and it typically follows that advice.
Gardasil is designed to protect against four strains of human papillomavirus, or HPV, which can cause cervical cancer and genital warts. HPV is spread mainly through sexual contact. There are more than 100 types of HPV, but the four strains Gardasil is designed to protect against account for about 70% of cervical cancer cases.
While Merck submitted data in support of using the proposed vaccine in both men and women, the FDA suggested it was considering approving the vaccine for use in women. An FDA background memo prepared for Thursday's meeting said the discussion would focus on the study results Merck submitted for females.
While the FDA said the vaccine would likely be capable of having a "significant impact" on reducing the number of cervical cancer cases, the agency raised a few concerns about the vaccine.
The agency said it would ask the panel to discuss whether the overall effectiveness of the vaccine might be "offset" by the fact that it doesn't protect against all HPV strains linked to cervical cancer. The FDA also raised a possible concern that the vaccine could make disease progression worse in women who had been infected with HPV prior to receiving the vaccine.
The panel will also be asked to discuss five congenital anomalies among infants born to recipients of Gardasil who were vaccinated near the time of conception.
However, the FDA indicated it was learning toward approving the vaccine because the agency said it was going to ask the panel for advice on how the product should be labeled, a discussion that typically occurs if the agency plans to approve something.
The FDA is expected to make a final decision on whether to approve the vaccine by June 8. If approved, Gardasil would be the first FDA-approved vaccine designed to protect against cervical cancer. GlaxoSmithKline PLC is working on a similar vaccine and hopes to submit it for FDA approval by the end of this year.
About 9,710 new cases of invasive cervical cancer are expected to be diagnosed in U.S. women this year, and about 3,700 women are expected to die from the disease, according to the American Cancer Society. Worldwide, Merck estimates cervical cancer kills about 290,000 women a year.
Ideally young women would receive the vaccine before they become sexually active and exposed to HPV. It can take 10 to 20 years after infection for cancer to appear, although most women infected with HPV don't develop cervical cancer.
Merck studied the vaccine in girls and women 9 to 26 years old. People receiving the vaccine would get three doses over about a six month period. The vaccine would not replace routine pap test-screening for cervical cancer. |
