Gilead halts trial in CLL and iNHL for Zydelig, as EMA initiates safety review

12 March 2016

The European Medicines Agency has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), following concerns over serious adverse events in ongoing clinical trials.

The drug, from US biotech major Gilead Sciences (Nasdaq: GILD), was authorized by the European Commission to treat two types of rare blood cancers called chronic lymphocytic leukemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma; The Pharma Letter September 19, 2014).

Following the EMA announcement on Friday, Gilead said it will terminate Zydelig trials in first-line CLL, iNHL, according to Bloomberg. The company said in a statement: “Gilead believes that Zydelig is an important treatment option for relapsed CLL and refractory iNHL patients who generally have limited effective therapeutic options, and is consulting with regulatory authorities on next steps.” The drug generated sales of $132 million in 2015 for the company.

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