The new approach would reduce the time and cost of bringing new treatments to patients. Under the draft guidance, drugs tested prior to surgical removal of tumors in certain types of high-risk patients with localized, early-stage disease would have an accelerated approval, according to the release.
The proposal is based on the I-SPY 2 TRIAL, a Phase II breast cancer trial under the Biomarkers Consortium, a partnership led by FNIH.
The FDA is accepting public comment on the new recommendations through July.
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