EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig

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.1

The review was 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 (a dummy treatment) in addition to other cancer medicines. Although the studies did not use the medicine in the same way as currently authorised, the risk of serious infection is considered relevant to the authorised use and the PRAC recommends that all patients treated with Zydelig should be given antibiotics to prevent Pneumocystis jirovecii pneumonia during treatment and for up to 2 to 6 months after treatment has stopped. Patients should also be monitored for infection and have regular blood tests for white cell counts because low counts can increase their risk of infection. Zydelig should also not be started in patients with a generalised infection.

At the beginning of the review the PRAC had advised as a precaution not to start Zydelig in patients with previously untreated CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation). The PRAC now concludes that Zydelig can again be initiated in these patients provided they cannot take any alternative treatment and that the measures agreed to prevent infection are followed.

The PRAC’s recommendations will now be passed to EMA’s Committee for Medicinal Products for Human Use (CHMP) for adoption of the Agency’s final position.

Posted on the EMA website on 8 July 2016