FDA Investigating Cancer Drug Amid Reports of Adverse Events, Including Deaths in Trials
Reports of adverse events, including deaths, has prompted Gilead Sciences to halt six clinical trials with Zydelig (idelalisib) in combination with other antineoplastic agents. The trials included patients with chronic lymphocytic leukemia, small lymphocytic leukemia, and indolent non-Hodgkin lymphomas.
Zydelig, a phosphatidylinositol 3-kinase inhibitor, is currently FDA-approved for the treatment of relapsed chronic lymphocytic leukemia, 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 small lymphocytic lymphoma in patients who have received at least two prior systemic therapies. The product is not indicated for the treatment of previously untreated chronic lymphocytic leukemia.
The FDA is currently reviewing the findings from the trials and will report new information as necessary. The agency is encouraging clinicians and patients to report adverse events associated with Zydelig to the FDA MedWatch program.
Originally posted on FDA.gov