The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration is alerting health care professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.
Gilead Sciences, Inc. has confirmed that they are stopping six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas. The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary.
Health care professionals should be aware that Zydelig is not approved for previously untreated chronic lymphocytic leukemia.
Zydelig is currently approved by the FDA 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.
- Relapsed small lymphocytic lymphoma in patients who have received at least two prior systemic therapies.
Patients should talk to their doctor if they have questions or concerns about Zydelig. The FDA urges health care professionals and patients to report adverse events involving Zydelig to the FDA MedWatch program.
This announcement is available at: Zydelig