National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
September 22, 2009 • Volume 6 / Number 18

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FDA Update

FDA Clears Test for Ovarian Cancer that Could Guide Surgical Decisions

Last week the FDA cleared the use of a blood test that can help determine whether a pelvic mass may be cancerous for women who have already been selected for surgery. When combined with other types of information, the test, called OVA1, can help patients and their health care providers decide which type of surgeries should be done and by whom, the FDA said in a statement.

Studies have shown that women with ovarian cancer survive longer when their surgeries are performed by gynecologic oncologists rather than by general gynecologists or surgeons. The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists have recommended that women be referred to a gynecological oncologist when specific signs of cancer are present.

OVA1 works by testing the blood levels of five proteins that vary in the presence of cancer. Based on these levels, the test produces an overall score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant. How the test is interpreted depends on a woman’s menopausal status.

The FDA decision was based on a study of 516 patients that compared OVA1 results with biopsy results. When combined with presurgical information, such as radiography and other laboratory tests, results from OVA1 tests identified additional patients who might benefit from an oncology referral who had not been identified using presurgical information alone, the agency said.

“Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications,” Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Committees Recommend FDA Approve Cervarix and Gardasil

Last week, the FDA received recommendations to approve two vaccines against the human papillomavirus (HPV) that causes cervical cancer.

The vaccine Cervarix is licensed in nearly 100 countries worldwide and approved by the World Health Organization, but it has been awaiting FDA approval since its initial application in 2007 raised concerns about possible side effects. Though structured as a bivalent vaccine to protect only against HPV types 16 and 18, Cervarix has been shown in a recent trial to provide cross-protection against three other HPV types and may also produce a higher degree of protection against precancerous lesions known as grade II cervical intraepithelial neoplasias (CIN2+) than the vaccine Gardasil.

Gardasil has been approved for cervical cancer protection in females aged 9 to 26 since 2006, and targets two additional HPV types that are linked to genital warts, which can occur in males, as well. A second expert committee recommended FDA approval be extended to males in that same age group. The clinical trials on which the committee based its recommendation showed that Gardasil was 89 percent effective in preventing genital warts and had no side effects, though it was less effective in those who had already been exposed to HPV.