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# Novartis sNDA for Zykadia Accepted for Review
- URL: https://www.fdaweb.com/novartis-snda-for-zykadia-accepted-for-review/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138050

FDA has accepted a Novartis supplemental NDA for expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The submission is based on the primary analysis of ASCEND-4, a global Phase 3 multicenter clinical trial which evaluated Zykadia compared to platinum-based chemotherapy in adult patients with Stage IIIB or IV ALK+ NSCLC. The study found that patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy, according to the company. A 45% risk reduction in PFS was obtained in the Zykadia arm compared to the chemotherapy arm, it says.