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FDA accelerates drug approval for patients with aggressive breast cancers

Robin Wulffson MD's picture
breast cancer, chemotherapy, FDA approval, promising drug, new drug

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.

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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.

The doctors noted that new drugs for breast cancer have historically been approved first for patients with metastatic disease who have few remaining options for systemic (whole body) treatment. Approval for an adjuvant (a drug that boosts the effect of another medication or therapy) indication occurs years later, after large, randomized trials with prolonged follow-up have been conducted in patients with early-stage disease. They noted that, recently, neoadjuvant (new adjuvant drugs) trials have introduced new drugs preoperatively in patients with localized breast cancer. The goal of this type of treatment is to render locally advanced cancers operable, facilitate breast-conserving surgery, and ultimately improve survival. In many of these neoadjuvant trials, the rate of pathological complete response (absence of residual invasive cancer on pathological evaluation of resected breast specimens and lymph nodes after preoperative therapy) has been used as the primary end point.

The FDA proposed that clinical trials would be structured so that women are treated with either chemotherapy or chemotherapy plus an experimental drug for a few months prior to surgery. The investigators would then compare response rates in the two groups, and if the drug was found to be significantly more effective in curing more cancers, it would receive accelerated approval. Following the clinical trial, the pharmaceutical manufacturers would be required to follow the women for several years to see if their cancers recurred. If the study participants continued to be disease-free, the pharmaceutical manufactures would receive full FDA approval for the treatment.


The New England Journal of Medicine

See also: No-touch breast scans reported ineffective for cancer detection