FDA accelerates drug approval for patients with aggressive breast cancers
New Food and Drug Administration (FDA) guidelines were released this week that grant accelerated approval of new drugs for use in women with aggressive, early-stage breast cancers. The approval was granted in the hope that their use might give them the best chance for a cure drug.
The decision will allow pharmaceutical manufacturers to test the drugs on a few months before they undergo breast cancer surgery, instead of waiting until the medication has been proven first in seriously ill patients. The FDA is accepting comments about its draft plan through the end of July.
The decision coincided with the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) held June 1-5 in Chicago, Illinois. Dr. Richard Pazdur, director of the FDA's cancer drug office, noted that the goal of this decision was to cure a woman of breast cancer via aggressive early chemotherapy. If the new drug proves to be effective, it will facilitate its full FDA approval.
The policy represents a significant departure from the current approach, in which promising drugs only are tested in earlier stage cancers after they have first proven to be safe and effective in advanced, metastatic cancer. Dr. Tatiana Prowell, a cancer specialist at Johns Hopkins in Baltimore and a medical officer for the FDA, added before the release of the new policy, if a patient with early stage breast cancer learned about a promising new drug for metastatic breast cancer, it probably would not be available for a decade,” said Dr. Tatiana Prowell, a cancer specialist at Johns Hopkins in Baltimore and a medical officer for the FDA. Drs. Prowell and Pazdur described the guidelines on May 30 in the New England Journal of Medicine.