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 leukemia ("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. The review started after a higher rate of serious adverse events related to infections, such as pneumonia, was seen in three clinical trials among patients who received either Zydelig or placebo in addition to other cancer medicines (see previous Jones Day Update). The PRAC's recommendations will now be passed to EMA's Committee for Medicinal Products for Human Use, or CHMP, for adoption of the Agency's final position.

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