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EMA starts review of Gilead Sciences’ Zydelig following safety concerns

Published on 14/03/16 at 09:40am

Regulators in Europe have initiated a safety review of Gilead Sciences’ (Nasdaq: GILD) blood cancer drug Zydelig (idelalisib) following reports of deaths and side effects during clinical trials.

The European Medicines Agency (EMA) said the increased rate of serious adverse, was seen in three clinical trials, in a combination study with other cancer medicines.

The regulator said it review the data from these studies to assess whether the findings have any consequences for the authorised uses of Zydelig.

In the EU, Zydelig is authorised for the treatment of, chronic lymphocytic leukaemia. It is used in combination with rituximab. In addition, the drug is also indicated for a type of non-Hodgkin lymphoma called follicular lymphoma.

The European regulators advised careful monitoring of patients starting or on treatment with Zydelig for signs of infections. If Zydelig is well tolerated, treatment should not be stopped.

Anjali Shukla

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