Health Canada issues safety warning on Zydelig
Medicines regulator Health Canada has issued a health warning on US biotech major Gilead Sciences’ (Nasdaq: GILD) blood cancer drug Zydelig (idelalisib).
Key messages from the agency were as follows:
- Decreased overall survival and an increased risk of serious adverse events (mostly infections) were observed in patients receiving Zydelig compared to the control groups in clinical trials.
- These trials evaluated the addition of Zydelig to standard therapies for first line treatment of chronic lymphocytic leukemia (CLL) and early line treatment of relapsed indolent non-Hodgkin’s lymphoma (iNHL).
- Zydelig should not be used for first line treatment of CLL.
- The Canadian Product Monograph for Zydelig will be updated to reflect this new information.
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