The PDUFA Date of March 26, 2011 is rapidly approaching and Bristol-Myers Squibb is justifiably hopeful that it will mark the approval of YERVOY (ipilimunab) for melanoma. The FDA gave this drug a priority review status but then delayed the PDUFA Date for 3 months for some reanalyses. This time should be the charm. Why? It’s a cancer drug that shows a survival benefit and that’s the name of the game with the FDA – show me the survival!!