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PRAC Concludes Review of Idelalisib and Issues Updated Recommendations for Use

EMA updated the recommendations on managing the risk of serious infections that were issued at the beginning of the review
20 Jul 2016
Haematologic malignancies;  Anticancer agents & Biologic therapy

The European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of idelalisib (Zydelig), confirming that the medicine’s benefits outweigh its risks in the treatment of 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. It updated the recommendations on managing the risk of serious infections that were issued at the beginning of the review.

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 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 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.

More about the medicine 

In the EU, Zydelig is authorised for the treatment of:

  • chronic lymphocytic leukaemia in patients who have received previous treatment as well as in previously untreated patients who have certain genetic mutations in their cancer cells (17p deletion or TP53 mutation) that make them unsuitable for treatment with a combination of chemotherapy medicines and immunotherapy. It is used in combination with rituximab;
  • follicular lymphoma where it is used on its own. 

More about the procedure

The review of Zydelig was initiated at the request of the European Commission on 11 March 2016, under Article 20 of Regulation (EC) No 726/2004. The review has been carried out by the PRAC, the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations. The PRAC recommendations will now be sent to the CHMP, responsible for questions concerning medicines for human use, which will adopt the Agency’s final opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

Last update: 20 Jul 2016

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