LONDON (Reuters) - European regulators have started a review into the safety of Gilead Sciences’ leukemia drug Zydelig due to concerns over serious adverse events, including deaths.
The review was prompted by an increased rate of harmful events, mostly due to infections, seen in three clinical trials that tested the drug in combination with other cancer medicines, the European Medicines Agency (EMA) said on Friday.
The EMA said it would review data from the studies to see if the findings had any consequences for Zydelig’s approved use. In the meantime, patients taking the drug should be carefully monitored for signs of infections, it said.
The agency added it was considering whether any other immediate measures were necessary while the review was ongoing.
Zydelig is authorized in Europe for treating chronic lymphocytic leukemia (CLL) in combination with Roche’s Rituxan and on its own for treating follicular lymphoma.
Reporting by Ben Hirschler, editing by Ed Osmond