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Roche wins CHMP nod for Alecensa licence extensions

Lung cancer monotherapy set for a broader European label

Roche

European regulatory advisors have given their backing to new uses of Roche’s lung cancer drug Alecensa (alectinib).

The Committee for Medicinal Products for Human Use (CHMP) recommended it be approved for a new indication as a first-line treatment for adults with anaplastic lymphoma kinase (ALK)- positive, advanced, non-small cell lung cancer (NSCLC).

The Committee also recommended Alecensa’s licence be extended to encompass second-line therapy in cases where Pfizer’s personalised NSCLC treatment Xalkori (crizotinib) can’t be used.

Sandra Horning, chief medical officer and head of global product development, Roche, said: “This is more great news for people with this type of lung cancer, bringing them closer to benefiting from Alecensa’s superior efficacy earlier in their treatment journey.”

Roche’s global phase III ALEX study not only showed Alecensa significantly reduced the risk of disease worsening or death by 53%, but the drug reduced the risk of tumours spreading to, or growing in, the brain or central nervous system by 84% compared to crizotinib.

Horning concluded: “The results from ALEX clearly showed the significant benefits of Alecensa over crizotinib and we are pleased this has been recognised by the CHMP.”

NSCLC accounts for around 80% of all lung cancers, and ALK-positive NSCLC make up around 5% of the total NSCLC population, which typically comprises of younger patients and smokers.

The CHMP recommendation comes in the wake of Roche’s recent award of US priority review status for Alecensa in a first-line setting from the US Food and Drug Administration (FDA).

Article by
Gemma Jones

16th October 2017

From: Sales

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