FDA Alert on Gilead Sciences’ Zydelig

The FDA has issued an alert for healthcare 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 has stopped 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.

Healthcare 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 healthcare professionals and patients to report adverse events involving Zydelig to the FDA MedWatch program.