Public recall detail

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

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Recall Safety notice
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Quick summary: ZYDELIG (idelalisib) - Increased Risk of Fatal and Serious Infections .

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Recall details

Quick summary: ZYDELIG (idelalisib) - Increased Risk of Fatal and Serious Infections .

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Affected product details

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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.

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