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Treats metastatic non-small cell lung cancer (NSCLC). NDA 211225, held by Novartis. Ceritinib.
As of Nov 15, 2026, NDA 211225 (Zykadia), held by Novartis, was first approved by FDA on Mar 18, 2019, with 2 approved supplements and 0 published complete response letters.
First approved: Mar 18, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
ZYKADIA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1, 2.1 )
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
