Posted 29 May 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) released new draft guidance for industry, providing an intended outline for sponsors hoping to utilize an accelerated approval pathway for drug-based preoperative breast cancer treatments.
FDA's 29 May issuance of the guidance is "intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant setting using pathologic complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations," the agency wrote in a Federal Register posting.
FDA pointed to the "unmet medical need" of breast cancer patients in issuing the guidance, which it hopes will encourage the further development of therapies and allow said therapies to come to market even sooner.
The draft guidance outlines the scenarios in which FDA will accept surrogate endpoints as proof of a product's effectiveness. Products accepted under an accelerated approval pathway would still be required to undergo further clinical testing after receiving approval from FDA, however.
In addition to outlining paths to approval, the draft guidance also proposes a "uniform definition" of pCR and issues advice for conducting adequate clinical trials.
Draft Guidance for Industry on Pathologic Complete Response in neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: use as an Endpoint to Support Accelerated Approval