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 Aug 2017
At a glance
- Drugs Alectinib (Primary) ; Crizotinib
- Indications Non-small cell lung cancer
- Focus Registrational; Therapeutic Use
- Acronyms ALEX
- Sponsors Roche
- 03 Aug 2017 According to a Genentech media release, the US FDA has accepted the company's sNDA and granted Priority Review for Alecensa (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic NSCLC as detected by an FDA-approved test. The FDA will make a decision on approval by November 30, 2017. This sNDA submission for Alecensa is based on results from the Phase III ALEX and Phase III J-ALEX studies.
- 06 Jun 2017 Primary results (data cut-off; 9 Feb 2017) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
- 05 Jun 2017 According to a Genentech media release, results from this trial will be published in the New England Journal of Medicine.