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FDA OKs Early Stage Trials

The regulatory agency will allow early-stage breast cancer patients to try experimental drugs previously reserved for those with advanced disease.

By | June 5, 2012

image: FDA OKs Early Stage Trials stock.xchng, Kurhan

STOCK.XCHNG, KURHAN

Breast cancer drug trials have, until now, exclusively targeted patients with advanced stages of disease for whom approved chemotherapy is no longer effective or an option.  But in a new document drafted by the US Food and Drug Administration (FDA) this week, the agency set guidelines for drug companies to test their new chemotherapy drugs on women with early-stage, yet aggressive breast cancers. Specifically, patients with highly aggressive triple-negative breast cancers still in the early stages will be eligible—bypassing years of rigorous testing on patients with late-stage, metastatic cancers.

"We're looking at introducing drugs into a very early stage of breast cancer, where a patient has a primary tumor and the chemotherapy is given before surgery," Richard Pazdur, director of the FDA's cancer drug office, said at the American Society of Clinical Oncology meeting in Chicago.

If treatment with the experimental drugs result in a pathologic complete response—meaning there is no detectable evidence of the cancer in the breast and lymph nodes—then the drugs could get FDA approval through an expedited process, The Chicago Tribune reported.

“There remains a significant unmet medical need for certain high-risk or poor prognosis populations of early-stage breast cancer patients,” the FDA stated in a summary of the document. “This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer.”

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Avatar of: Barry Brewer

Barry Brewer

Posts: 1457

June 6, 2012

It is about time. It has been known for some time that Cancers develope multiple mutations the more advanced they are. Treating them with gene corrective therapeutics can avoid those downstream mutations.

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