EU follows USA in approving first-line use of ALK inhibitor Alecensa for NSCLC

23 December 2017

The European Commission has granted a marketing authorization for Alecensa (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC), Swiss pharma giant Roche (ROG: SIX) has announced.

The approval is based on results from the Phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 53% (hazard ratio (HR)=0.47, 95% confidence interval (CI): 0.34-0.65, p<0.001) compared to crizotinib. The study also showed that Alecensa reduced the risk of tumors spreading to, or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10-0.28, p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favorably to crizotinib.

Set to challenge Xalkori and Zykadia

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