The European Medicines Agency (EMA) has started a review of idelalisib (Zydelig, Gilead Sciences), which is authorized in the European Union to treat patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma.
The review stems from an increased rate of serious adverse events including deaths, mostly due to infections, seen in three clinical trials testing the drug in combination with other cancer therapies, the EMA explains in a news release.
The review of idelalisib was requested of the European Commission and is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines.
The clinical trials involved patients with CLL and indolent non-Hodgkin lymphoma. The study in CLL investigated combinations of medicines that are currently not approved and the studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indications, EMA said.
"Investigators of all clinical trials involving Zydelig are currently being informed of the actions to be taken in relation to the conduct of ongoing studies," EMA said.
The agency will review the data from these studies to determine whether the findings have any consequences for the authorized uses of Zydelig. "In the meantime, patients starting or on treatment with Zydelig should be carefully monitored for signs of infections. If Zydelig is well tolerated, treatment should not be stopped," EMA said. EMA is also considering whether any other immediate measures are necessary while the review is in progress.
Following conclusion of the PRAC review the committee will make a set of recommendations, which will be forwarded to the Committee for Medicinal Products for Human Use, the committee responsible for questions concerning medicines for human use, which will adopt a 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.
Idelalisib was approved for CLL and for relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma in the US in 2014.