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Home Industry News Gilead Sciences ceases successful leukaemia drug trial early

Gilead Sciences ceases successful leukaemia drug trial early

10th October 2013

Gilead Sciences has announced that it will be bringing Study 116, a phase III trial of its chronic lymphocytic leukaemia (CLL) therapy idelalisib, to an early conclusion.

An independent data monitoring committee has recommended an early cessation to the trial – which was evaluating idelalisib in previously-treated CLL patients who are not fit for chemotherapy – based on an interim analysis showing its significant efficacy performance.

Patients from Study 116 who were receiving idelalisib will continue to do so, while those in the placebo group will become eligible to receive open-label idelalisib therapy in an extension study.

Gilead has already filed for US regulatory approval of the new drug, with an application to follow covering the EU later this year.

Dr Norbert Bischofberger, Gilead's executive vice-president for research and development and chief scientific officer, said: "This is the first phase III study to report positive results for a new class of targeted therapies that inhibit B-cell receptor signalling as a major component of their mechanism of action."

This comes after the company was last month granted EU approval for Tybost, a new boosting agent for HIV therapy.ADNFCR-8000103-ID-801647886-ADNFCR

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