publication date: Dec. 11, 2015
FDA Approves Alecensa for ALK-Positive NSCLC Patients
FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, who have progressed on or are intolerant to crizotinib.
In two studies, Alecensa shrank tumors in ALK-positive NSCLC patients who progressed on crizotinib, with objective response rates of 38 percent (95% CI 28-49) and 44 percent (95% CI 36-53).
The first study is a phase II single-arm, open-label trial evaluating 87 patients. The second study is a phase I/II global, single-arm, open-label trial evaluating 138 patients. Both administered 600 mg of Alecensa orally twice daily.
In a pooled subset analysis of the two studies, patients with tumors that spread to the brain or other parts of the central nervous system demonstrated an ORR of 61 percent (95% CI 46-74).
The indication for Alecensa is approved based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Alecensa is being studied in a global, randomized phase III study comparing Alecensa to crizotinib as an initial treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by Ventana ALK (D5F3) CDx Assay developed by Roche Diagnostics.
Alecensa will be available to people in the U.S. within two weeks, according to the drug’s sponsor, Genetech, a member of the Roche Group.
FDA approved Vistogard … Continue reading 41-45 FDA Approves Alecensa for ALK-Positive NSCLC Patients
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