Gilead Sciences Inc. has halted six clinical trials involving the cancer drug Zydelig. This came about after patient deaths occurred. The U.S. Food and Drug Administration (FDA) issued an alert in a statement on March 14. The FDA’s alert followed similar news out of Europe on March 11. European regulators reported an increased rate of deaths attributable to infections in three clinical trials involving Zydelig. All the trials in question have been exploring the use of Zydelig in combination with other cancer drugs to treat distinct types of leukemia and lymphoma. The FDA alert said: “The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary.”
Details on the number of deaths were not immediately available. In a statement on March 11, the European Medicines Agency (EMA) said it would review trial data “to assess whether the findings have any consequences for the authorized uses of Zydelig.” In the meantime, patients should be “carefully monitored” for signs of infection, the EMA said. It was unclear what other drugs were being used in combination with Zydelig. But European regulators said that at least one of the trials involved “combinations of medicines that are currently not approved.”
Zydelig, or idelalisib, was approved in the U.S. in 2014 to treat three types of blood cancers in relapsing patients. The drug carries black box warnings about serious and fatal side effects related to liver damage, diarrhea, intestinal perforation and an inflammatory lung condition called pneumonitis. The product is a first-in-class kinase inhibitor, according to Gilead. In its 2014 annual report, Gilead called Zydelig “a new therapy for patient populations with few other options.”
Studies leading up to Zydelig’s clearance appeared to show significant benefits, according to the FDA. For example, a trial involving leukemia patients treated with Zydelig and the biologic Rituxan found a potential for almost 11 months of survival without disease progression, compared with 5.5 months for patients treated with a placebo and Rituxan.
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