- The European Medicines Agency (EMA) has started a review of Gilead's cancer drug Zydelig (idelalisib) due to an increased incidence of serious adverse events in clinical trials, including infection-related deaths. These events have occurred in three clinical trials, one of which combines Zydelig with an unapproved drug.
- The clinical trials in question involve patients with CLL and indolent non-Hodgkin's lymphoma. According to its statement, the EMA will review data from these studies to determine if the adverse events should impact Zydelig’s current authorizations.
- Zydelig is currently used both as monotherapy for treatment of follicular lymphoma and as part of combo therapy with Roche's Rituxan (rituximab) for treatment of chronic lymphocytic leukemia (CLL).
EMA authorities have notified clinical trial investigators who are evaluating Zydelig in trials involving new combo therapies. The agency advised monitoring of patients beginning or on treatment of Zydelig although treatment should not be stopped if well-tolerated.
In the CLL trial, Zydelig was combined with a unapproved medicine, while the two non-Hodgkin lymphoma studies involved indications for which Zydelig is not approved.
Zydelig was approved in the U.S. in July 2014, and subsequently approved in the E.U. that following September.
The question now is whether certain combinations of drugs with Zydelig are more likely to lead to infections than other combinations. The Pharmacovigilance Risk Assessment Committee (PRAC) will conduct the review and present findings to the EMA for final opinions.