FDA and EMA Warn of Adverse Events Associated with Zydelig

March 15, 2016
Pharmaceutical Technology Editors

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

FDA and the European Medicines Agency (EMA) issued statements in March 2016 about reports of an increased rate of adverse events, including death, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines. According to FDA, Gilead Sciences, a research-based biopharmaceutical company, has confirmed that they are stopping six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and indolent non-Hodgkin lymphomas. FDA says healthcare professionals should be aware that Zydelig is not approved for previously untreated chronic lymphocytic leukemia.

Zydelig is currently approved by 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.

At the request of the European Commission, EMA has also begun a review of the drug, which is approved to treat chronic lymphocytic leukemia and follicular lymphoma in the European Union. EMA is conducting the review after increased numbers of serious adverse events occurred in clinical trials with the drug, including death, which the agency said in a press announcement is “mostly due to infection.” The agency says they plan to review the findings, and determine if there are any consequences for authorized uses for the treatment. 

Source: FDA, EMA