Idelalisib (Zydelig) may increase morbidity and mortality when used with other antineoplastic agents
March 18, 2016
Idelalisib (Zydelig) increased the risk of adverse events and death in 6 clinical trials in leukemia and lymphoma patients when used with other antineoplastic agents. Many of these events were related to infections. Gilead Sciences has stopped the 6 trials, and FDA is investigating the clinical data from the trials.
Idelalisib is labeled for treatment of relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small cell lymphocytic leukemia, in patients given at least 2 prior chemotherapies. Idelalisib is also labeled for use with rituximab for treatment of relapsed chronic lymphocytic leukemia, when rituximab monotherapy is also appropriate.
Monitor patients receiving idelalisib closely, particularly for signs of infection. Report adverse events with idelalisib to the FDA MedWatch reporting program.
Additional information is available at the following links:
- MedWatch Alert:
- European Medicines Agency (EMA) Press Release:
March 18, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.