Posted by Michael Wonder on 06 Nov 2017
FDA approves Genentech’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer
6 November 2017 - Approval based on Phase III results that showed Alecensa extended the average time that people lived without their disease worsening compared to crizotinib.
Genentech today announced that the U.S. FDA approved the supplemental new drug application for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
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 475 (HR=0.53, 95% CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by independent review committee (IRC). Median PFS was 25.7 months (955 CI: 19.9, not estimable) for people who received Alecensa compared with 10.4 months (955 CI: 7.7, 14.6) for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies.
