Decreased overall survival and increased risk of serious infections in patients receiving Zydelig® (idelalisib) for first line treatment of Chronic Lymphocytic Leukemia (CLL) and relapsed Indolent Non-Hodgkin Lymphoma (iNHL)

Gilead Sciences would like to inform healthcare professionals about new important safety information regarding the use of Zydelig®. Decreased overall survival and increased rate of serious adverse events have been observed in patients receiving Zydelig® compared to the control groups in three ongoing Phase 3 studies, evaluating the addition of Zydelig® to standard therapies in first line treatment of CLL and relapsed iNHL/small lymphocytic lymphoma (SLL). The majority of events were infections, which included sepsis and pneumonia. Healthcare professionals are advised to counsel patients about the risk of serious and/or fatal infections.  During treatment with Zydelig®, all patients should be administered prophylaxis for pneumocystis pneumonia and monitored for cytomegalovirus. Zydelig® should be permanently discontinued in patients with evidence of infection or viremia (positive PCR or antigen test). Blood count monitoring is recommended in all patients at an interval of at least every 2 weeks for the first 6 months of treatment with Zydelig®, and at least weekly in patients while absolute neutrophil count is less than 1.0 Gi/L. Published: 13 Apr 2016

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