Posted by Michael Wonder on 21 Dec 2017
European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer
21 December 2017 - Approval based on phase III ALEX data showing Alecensa reduced the risk of disease progression or death by more than half versus crizotinib.
Roche today announced that the European Commission has granted a marketing authorisation 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.
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 tumours spreading to, or growing in the brain or central nervous system 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 favourably to crizotinib.
