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

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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