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Home Industry News Roche’s Alecensa recommended by CHMP in new lung cancer indication

Roche’s Alecensa recommended by CHMP in new lung cancer indication

17th October 2017

Roche has announced that its cancer drug Alecensa has been recommended for European regulatory approval in a new lung cancer indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alecensa as a monotherapy for the first-line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC).

Additionally, the CHMP simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa as a second-line treatment when crizotinib fails to a full marketing authorisation.

These recommendations are based on the findings of the phase III ALEX study, which showed that Roche's drug is able to deliver significant progression-free survival improvements while preventing tumours from spreading to the brain or central nervous system.

Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "The results from ALEX clearly showed the significant benefits of Alecensa over crizotinib and we are pleased this has been recognised by the CHMP."

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