The US Food and Drug Administration (FDA) is seeking to improve the much-criticized accelerated approval program by reviewing six drugs approved under this pathway. The agency's Oncologic Drugs Advisory Committee (ODAC) held a meeting on February 8 to scrutinize Eli Lilly's Erbitux (cetuximab), GlaxoSmithKline's Bexxar (tositumomab) and Arranon (nelarabine); Genzyme's Clolar (clofarabine), Amgen's Vectibix (panitumumab) and Novartis' Gleevec (imatinib). The committee's intention was to analyze the process that brought these drugs to market without full confirmation that they are safe and effective. ODAC concluded that to grant accelerated approval, the agency should require a randomized trial, which could measure a surrogate endpoint. The panel also proposed that at the time of gaining accelerated approval, two randomized controlled trials should be under way. “The real issue is that lots of drugs are approved that are not terribly efficacious,” argues Laurence Baker, chairman of the Southwest Oncology Group, Ann Arbor, Michigan, who was not on the panel. Recently, for instance, the agency withdrew the breast cancer indication for Avastin (bevacizumab),given accelerated approval in 2008, after studies found the drug did not provide asurvival advantage (Nat. Biotechnol. 29, 3–15, 2011).