EMA recommends new safety measures for Gilead's Zydelig

Following the announcement last week that it had been asked by the European Commission to start a review of the cancer medicine Zydelig (idelalisib), relating to concerns over serious adverse events in ongoing clinical trials (The Pharma Letter March 12), the European Medicines Agency’s today said its Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using to ensure that the drug continues to be used as safely as possible.

Marketed by US biotech giant Gilead Sciences (Nasdaq: GILD), Zydelig is currently authorized in the European Union to treat two types of blood cancers called chronic lymphocytic leukemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).

Drug regulators in other major countries, including the USA, Canada and Australia, have also issued statements that they are looking into the safety of Zydelig. On Monday, the US Food and Drug Administration issued an alert noting: "The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary." Four Canadian clinical trials, involving Zydelig in combination with other cancer medicines, were being stopped, said Health Canada.