FDA Discontinues Iclusig® REMS Program

FLASCO has been notified that Takeda Oncology was recently advised by the U.S. Food and Drug Administration (FDA) that the REMS (Risk Evaluation and Mitigation Strategy) communication plan for ICLUSIG® (ponatinib) is no longer required. After a comprehensive assessment, FDA determined the ICLUSIG REMS communication plan had met its goals. As a result, the REMS communication plan is no longer needed, and the risks with ICLUSIG can be adequately conveyed through product labeling.