The HPV vaccine Gardasil is not yet approved for women aged 27 to 45, according to a "complete response" letter to the vaccine's manufacturer, Merck & Co., from the Food and Drug Administration (FDA). The FDA wrote that its review of the company's supplemental biologics license application (sBLA) to add women 27 to 45 as an approved indication is complete, but that the vaccine will not be approved within the 6-month "priority review" period due to issues with the submission.

Merck expects to submit its responses this month, the company noted in a statement. Gardasil is already approved for use in females aged 9 to 26 for the prevention of HPV 6, 11, 16, and 18 infection.

The sBLA was based on data from a study of 3,800 women aged 24 to 45, who were free from infection by at least one of the four HPV types covered by the vaccine. Gardasil prevented 91 percent of persistent HPV infections, low-grade cervical abnormalities, and precancers caused by one of those four HPV types compared with women given placebo. The prevention rate for those endpoints was 83 percent when the analysis was limited to HPV types 16 and 18, which are responsible for approximately 70 percent of cervical cancer cases.

The FDA issued a second complete response letter to Merck regarding an sBLA to market Gardasil as "cross-protection" against HPV types not specifically covered by the vaccine.

"According to the FDA, the data submitted do not support extending the indication for Gardasil to include nonvaccine HPV types," Merck said.

HER2 Test for Breast Cancer Approved

A genetic test that can help identify women with breast cancer who are candidates for the drug trastuzumab (Herceptin) was approved by the FDA today. The test measures the number of copies of the gene HER2 in tumor tissue; women with extra copies of this gene may benefit from trastuzumab.

The SPOT-Light HER2 CISH kit involves staining a small sample of tumor tissue. The stain causes tissue with extra copies of HER2 to change color. "The color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscope," according to a statement by the FDA.

Unlike existing tests, the SPOT-Light, which is manufactured by Invitrogen Corp., allows labs to store the tissue for future reference, the FDA said.