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The European Medicines Agency (EMA) has launched a safety review of idelalisib (Zydelig), which is authorised for the treatment of two rare blood cancers, after data from three clinical trials suggest an increased risk of death associated with the drug.
Idelalisib is licensed in the EU to treat chronic lymphocytic leukaemia and follicular lymphoma, a type of non-Hodgkin lymphoma, but new evidence has emerged about the risk of serious adverse events relating to it in combination with other drugs. The increased reports of serious adverse events included deaths, mostly due to infections.
The clinical trials involved patients with chronic lymphocytic leukaemia and indolent non-Hodgkin lymphoma. But the EMA points out that the chronic lymphocytic leukaemia study was looking at combinations of medicines that are currently unapproved, while the non-Hodgkin lymphoma studies included patients with disease characteristics that are different from those covered by the current EMA-approved indications.
The EMA intends to review the data to see if there is any need to change current recommendations. In the meantime, it is advising that patients who are starting treatment with idelalisib should be monitored carefully for signs of infection. Treatment should continue in patients where the drug is well tolerated, the EMA says.
The safety review was requested by the European Commission and is being carried out by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Any proposals by the PRAC will be forwarded to the Committee for Medicinal Products for Human Use, which will make a final recommendation to the European Commission.
