Posted by Michael Wonder on 26 May 2017
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer
26 May 2017 - In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival was 16.6 months, compared to 8.1 months with chemotherapy.
Novartis today announced the US FDA approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.
Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib. In January 2017, the FDA granted Zykadia breakthrough therapy designation for the first-line treatment of patients with ALK-positive metastatic NSCLC with metastases to the brain, and priority review for first-line ALK-positive metastatic NSCLC.
