FDA Alerts Clinicians About Deaths With Idelalisib Plus Other Drugs

There is an increased rate of adverse events, including deaths, in clinical trials with idelalisib in combination with other cancer medications, according to a report by the U.S. Food and Drug Administration (FDA) to alert clinicians.¹

Gilead Sciences, Inc., developer of idelalisib, has terminated 6 clinical trials in patients with chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), and indolent non-Hodgkin lymphomas.

The FDA is currently the findings of the clinical trials and will release new information regarding the increased risk of adverse events and fatality if necessary.

The FDA’s statement also alerts clinicians to be aware that idelalisib, a PI3Kδ kinase inhibitor is not indicated for the treatment of treatment-naïve patients with CLL.

The drug is currently approved by the FDA for the treatment of: 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.

The most frequently reported adverse reactions associated with idelalisib treatment are diarrhea, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash. The most common laboratory abnormalities are neutropenia, hypertriglyceridemia, hyperglycemia, elevated ALT, and elevated AST.

Reference

1. FDA alerts healthcare professionals about clinical trials with Zydelig (idelalisib) in combination with other cancer medicines [news release]. Silver Springs, MD: U.S. Food and Drug Administration; March 14, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm490618.htm? source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 16, 2016.