- FDA, European drug regulators are reviewing Gilead treatments
- Deaths, side effects reported after drug used in combination
U.S. and European regulators are reviewing Gilead Sciences Inc.’s cancer drug Zydelig after some patients died or suffered other side effects while taking it with other drugs in clinical trials.
The European Medicines Agency will look at the data from those three clinical trials to see whether they mean anything for patients taking the drug for uses that have already been approved, according to a statement Friday. Zydelig has received approval in Europe and the U.S. to treat some forms of blood cancer.
The U.S. Food and Drug Administration is “aware of and is looking into reports of deaths” with Zydelig during clinical trials, Angela Stark, an agency spokeswoman, said in an e-mail.
“The safety of patients is a top priority and the FDA will communicate new safety-related information on Zydelig as it becomes available,” Stark said.
The side effects associated with the medication were driven by a rise in infections, the regulators said. They were seen in patients either taking unapproved drugs in combination with Zydelig, or in patients that included those not currently approved to take the drug in Europe. Zydelig is predicted to bring in $821 million in sales in 2020, according to an average of seven analysts’ estimates compiled by Bloomberg.
European regulators advised doctors to monitor those now on Zydelig for infections and keep patients taking the drug on it if they are responding well to treatment.
Gilead is aware of the findings and is halting several studies looking at the drug’s use in patients with the same blood cancers as those who had the severe side effects, according to Sonia Choi, a company spokeswoman. Some patients with indolent non-Hodgkin lymphoma were receiving Zydelig after other forms of treatment or as a first therapy. Another group of patients with chronic lymphocytic leukemia was taking Zydelig as a first drug. The drug is currently approved in the U.S. and Europe to treat those with CLL whose cancer has returned after other therapies.
The company still believes the drug is a good option for patients with both cancer types whose disease has returned, Choi said, and is discussing how to proceed with regulators.
Gilead shares rose 1.1 percent to $89.65 at the close in New York.