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# FDA Allows Expanded Use for Novartis’ Zykadia
- URL: https://www.fdaweb.com/fda-allows-expanded-use-for-novartis-zykadia/
- Published: 2017-05-30T12:00:00.000Z
- Updated: 2026-09-14T22:26:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138808

FDA has approved the expanded use of Novartis’ 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. Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib.

  
The first-line approval of Zykadia is based on results from the open-label, Phase 3 ASCEND-4 trial. The study demonstrated that patients treated with first-line Zykadia had a median progression-free survival of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance, according to the company.