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By R. Angelo de Claro, MD, Edvardas Kaminskas, MD, Ann Farrell, MD, and Richard Pazdur, MD  / September 15, 2013

FDA on CLL Drug Approval and Expanded Access

The ASCO Post article, “Ibrutinib CLL Trial: Where is the Equipoise?” published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the...