Compliance Management / Large Molecule

Gilead Stops Six Trials Due to Adverse Events, Death

Mar 15, 2016

Gilead Sciences has stopped six clinical trials using its drug idelalisib (Zydelig) in combination with other cancer drugs due to a higher rate of serious adverse events, including death, according an FDA press release.

European Union (EU) regulators also announced the review of idelalisib in response to an increased rate of serious adverse events including death in three clinical trials that combined the Gilead drug with other cancer drugs.

Idelalisib is approved in the United States to treat relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab; relapsed follicular B-cell non-Hodgkin lymphoma, which is classified as indolent; and relapsed small lymphocytic lymphoma.

FDA is reviewing the findings of the six clinical trials, and it warns health care professionals that Zydelig is not approved for previously untreated chronic lymphocytic leukemia.