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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