EMA to review Gilead’s Zydelig over safety concerns

The European Medicines Agency (EMA) has announced that it has started a review of Gilead’s cancer drug Zydelig (idelalisib).

The therapy is authorised in the EU to treat chronic lymphocytic leukaemia and follicular lymphoma.

The EMA says 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 Zydelig are currently being informed of the actions to be taken in relation to the conduct of ongoing studies.

The EMA has said it will now review the data from these studies to assess whether the findings have any consequences for the authorised 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.

The EMA is considering whether any other immediate measures are necessary while the review is ongoing. The Agency will communicate further and keep doctors and patients informed as appropriate.