Cervical-Cancer Drug Is Touted
June 6, 2006
A new study found that a proposed cervical cancer vaccine by British drug maker GlaxoSmithKline PLC produced an immune response in women ages 26-55, indicating the vaccine could help prevent cases of the disease in older women.
The vaccine, Cervarix, is designed to prevent infection with human papillomavirus (HPV), the most common STD in the United States. While there are more than 100 strains of HPV, Cervarix targets the two types -- HPV 16 and HPV 18 -- that account for around 70 percent of cervical cancer cases.
The Phase III trial of Cervarix included 666 women ages 15-55 who received injections of the vaccine. Researchers found 100 percent of the women developed antibodies to HPV types 16 and 18. A previous study of Cervarix in females ages 15-25 showed it was 100 percent effective for 4.5 years at stopping infection by types 16 and 18, and in preventing cervical lesions that could lead to cervical cancer.
Rival drug maker Merck & Co. is expecting Food and Drug Administration approval this week to sell its cervical cancer vaccine Gardasil. However, studies of Gardasil have primarily focused on women age 26 and younger, and approval would likely be for use in girls and women ages 9-26. The company also submitted data on boys ages 9-15 showing Gardasil produced an immune response.
Noting that Cervarix is "generally safe and well-tolerated," Glaxo said it will submit all of its study data to FDA by year's end in hopes of it being approved for women up to age 55.
Wall Street Journal
06.06.06; Jennifer Corbett Dooren
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.