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FDA Approves Ceritinib for Frontline ALK+ NSCLC

Jason M. Broderick @jasoncology
Published: Friday, May 26, 2017

The FDA has approved ceritinib (Zykadia) for the treatment of patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), according to Novartis, the manufacturer of the second-generation ALK inhibitor.

-positive advanced NSCLC previously treated with crizotinib (Xalkori). Today's FDA action also converts that second-line approval into a full approval.
de Castro G, Tan DS, Crinò L, et al. First-line Ceritinib Versus Chemotherapy in Patients With ALK-rearranged (ALK+) NSCLC: A Randomized, Phase 3 Study (ASCEND-4). Presented at: Presented at: 17th World Lung Cancer Conference, the Annual Meeting of the International Association for the Study of Lung Cancer (IASLC); December 4-7, 2016; Vienna, Austria.

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View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Advances in™ Therapies for Patients With ALK-Positive Lung Cancers: More Options…More Decisions…Better OutcomesAug 30, 20191.5
Oncology Briefings™: Treating Advanced NSCLC Without Actionable MutationsAug 30, 20191.0
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