EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig (idelalisib), confirming that the medicine’s benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukaemia (CLL) and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia and has updated recommendations to manage this risk issued at the beginning of the review.
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PRAC concludes review of Zydelig and issues updated recommendations for use