COPIKTRA REMS Safety Update

September 4, 2020

ASCO has been notified about a recent safety update relating to the drug COPIKTRATM (duvelisib) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program. A REMS Safety Information Fact Sheet has been released to address the following risks of fatal and/or serious toxicities associated with use of COPIKTRATM: (1) infections, (2) diarrhea or colitis, (3) cutaneous reactions, (4) and pneumonitis reactions. More information for healthcare providers can be found on the COPIKTRATM REMS website for healthcare professionals. 

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