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Health Canada Health products

ZYDELIG (idelalisib) - Increased Risk of Fatal and Serious Infections

Issued May 3, 2016
Issue
Decreased overall survival and increased rate of serious adverse events have been observed in patients receiving ZYDELIG compared to the control groups in Phase 3 studies evaluating the addition of ZYDELIG to standard therapies for first line treatment of CLL and early lines of relapsed iNHL. The majority of events were infections, which included sepsis and pneumonia.
Hazard description
Product safety