A RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT-NAIVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 30 Nov 2017
At a glance
- Drugs Alectinib (Primary) ; Crizotinib
- Indications Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms ALEX
- Sponsors Roche
- 06 Nov 2017 According to a Genentech media release, the FDA has converted Alecensa's initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.
- 06 Nov 2017 According to a Genentech media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The approval is based on results from this study.
- 18 Oct 2017 Results of first follow-on companion diagnostics (CDx) ALK test using comprehensive genomic profiling as a part of our universal CDx platform presented at the 18th World Conference on Lung Cancer