EMA reviews Zydelig (idelalisib) in CLL and follicular lymphoma due to serious adverse events- Gilead Sciences

The European Medicines Agency (EMA) has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), from Gilead Sciences. Idelalisib is authorised in the EU to treat chronic lymphocytic leukaemia and follicular lymphoma (a type of non-Hodgkin lymphoma). The review has been started because an increased rate of serious adverse events including deaths, mostly due to infections, was seen in three clinical trials investigating the medicine in combination with other cancer medicines. The clinical trials involved patients with chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma. However, the study in chronic lymphocytic leukaemia 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.

Investigators of all clinical trials involving idelalisib are currently being informed of the actions to be taken in relation to the conduct of ongoing studies. EMA will now review the data from these studies to assess whether the findings have any consequences for the authorised uses of idelalisib. In the meantime, patients starting or on treatment with idelalisib should be carefully monitored for signs of infection. If idelalisib is well tolerated, treatment should not be stopped.