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FDA Halts Six Idelalisib Combination Studies

This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

Six clinical trials exploring idelalisib (Zydelig) in combination with other therapies have been halted due to reports of an increased rate of adverse events, including death, for patients with hematologic malignancies, according to an alert issued by the FDA. 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 announcement follows a similar decision from the European Union, which placed idelalisib under a safety review following reports of infections that were associated with the medication.

“The US Food and Drug Administration is alerting 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,” the FDA said in a statement. “The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary.” The FDA noted in its alert that idelalisib is currently not approved for untreated patients with CLL.

Dr. Furman, a member of our scientific advisory board, offers this comment:

There has been several announcements made regarding idelalisib (Zydelig) over the past several days. In essence, there was an increase in deaths in several studies in the patients receiving idelalisib compared with placebo. These deaths were mostly infection related and seen in patient who had received minimal prior therapy. As a result, several idelalisib trials involving treatment naïve patients are being closed.

For those already on idelalisib and receiving benefit, this should not necessarily result in you changing your treatment plan. This is something to discuss with your physician. The official recommendations will likely involve using prophylaxis for PCP and monitoring for CMV.

See more at:

http://www.onclive.com/web-exclusives/fda-halts-six-idelalisib-combination-studies#sthash.qeardg1Q.dpuf

http://www.fda.gov/Drugs/DrugSafety/ucm490618.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.bloomberg.com/news/articles/2016-03-11/gilead-cancer-drug-reviewed-by-eu-after-deaths-in-combo-trails