What is a mammogram? A mammogram is a safe, low-dose x-ray picture of the breast. It is currently the most effective method of detecting breast cancer in its earliest, most treatable stages. Why should I have a mammogram? A mammogram can find breast cancer that is too small to be seen or felt. If breast [...]
FOR IMMEDIATE RELEASE July 8, 2008 Media Inquiries: Karen Riley, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). The SPOT-Light [...]
About a month after being vaccinated against the cervical cancer-causing HPV virus, 13-year-old Jenny Tetlock missed the lowest hurdle in gym class, the first hint of the degenerative muscle disease that, 15 months later, has left the previously healthy teenager nearly completely paralyzed. Did the vaccine, Gardasil, cause her condition? Her father, Philip Tetlock, a psychology professor at UC-Berkeley’s Haas School of Business, has embarked on an odyssey to find out whether the vaccine or random coincidence is to blame.
GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK’s Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.
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