Beyond Fast Track for Drug Approvals

In recent years, the Food and Drug Administration (FDA) has granted fast-track approval for cancer treatments that are effective in only 10 to 15 percent of patients, without requiring sponsors to identify the patients who are most likely to benefit. In this article, the authors propose that the FDA make rapid approval of new molecularly targeted cancer therapies contingent on sponsors' agreement to invest in research designed to identify subgroups of patients who are likely to have a response to treatment.