FDA Alert on Idelalisib in Combination with other Cancer TreatmentsPosted: March 22, 2016
On March 14, three days after a similar announcement from the European Medicines Agency (EMA) the Food and Drug Administration (FDA) issued an alert to healthcare professionals concerning the use of idelalisib (Zydelig) in combination with other cancer treatments. Following reports of increased adverse events including deaths linked to idelalisib during clinical trials, Gilead Sciences, stopped six clinical trials for patients with chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), and indolent non-Hodgkin lymphoma.
Idelalisib is currently approved for use in relapsed CLL, in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities, relapsed follicular B-cell non-Hodgkin lymphoma in patients who have received at least two prior systemic therapies, and relapsed SLL in patients who have received at least two prior systemic therapies. These approvals were based on phase 2 and phase 3 studies that had demonstrated significant evidence of benefit relative to standard therapies. The recent FDA/EMA announcements have not commented on the approved indications for idelalisib.
Doctors at Weill Cornell Medicine take patient safety very seriously. Patients currently taking idelalisib are encouraged to discuss any concerns they may have with their physician.