Regulatory Focus™ > News Articles > Gilead Halts Six Cancer Trials as EMA, FDA Warn of Increased Adverse Events

Gilead Halts Six Cancer Trials as EMA, FDA Warn of Increased Adverse Events

Posted 15 March 2016 | By Zachary Brennan 

Gilead Halts Six Cancer Trials as EMA, FDA Warn of Increased Adverse Events

Biotech juggernaut Gilead Sciences is halting six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas after an increased rate of serious adverse events, including deaths, mostly due to infections.

The US Food and Drug Administration (FDA) late Monday issued an alert to health professionals of the stoppages, noting that they should be aware that the cancer medicine Zydelig (idelalisib) is not approved for previously untreated chronic lymphocytic leukemia.

Zydelig is, however, 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’s 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.

FDA’s announcement of its review of the findings of the clinical trials came four days after the European Medicines Agency (EMA) announced that at the request of the European Commission, it began a review of Zydelig, which is authorized in the EU to treat chronic lymphocytic leukemia and follicular lymphoma (which is part of the group of cancers called non-Hodgkin lymphoma).

“The review has been started because an increased rate of serious adverse events, including deaths, mostly due to infections, was seen in three clinical trials investigating the medicine in combination with other cancer medicines. The clinical trials involved patients with chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma. However, the study in chronic lymphocytic leukaemia investigated combinations of medicines that are currently not approved and the studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indications,” EMA said.

Investigators of all clinical trials involving Zydelig are currently being informed of the actions to be taken in relation to the conduct of ongoing studies.

EMA will now review the data from these studies to assess whether the findings have any consequences for the authorized uses of the cancer drug. In the meantime, patients starting or on treatment with Zydelig should be carefully monitored for signs of infections, EMA said, noting that if Zydelig is well tolerated, treatment should not be stopped.

FDA Alert

EMA Notice


Categories: Regulatory News

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