FDA approves expanded use of Zykadia

The US Food and Drug Administration has approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.

Swiss pharma giant Novartis’ (NOVN: VX) 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.

The market for NSCLC treatments across eight major markets is estimated to be worth more than $7 billion, and is currently growing very strongly. Zykadia b generated revenues of $91million last year. For comparison, Roche’s Alecensa (alectinib) sales were around $180 million last year while Pfizer recorded $927 million in sales from Xalkori (crizotinib).