FDA expands approval of Zykadia (ceritinib) to include patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase (ALK)-positive- Novartis

The FDA has approved the expanded use of Zykadia (ceritinib), from Novartis, 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. 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 first-line approval of Zykadia is based on results from an open-label, randomized, multicenter, global, Phase III trial, ASCEND-4. The study demonstrated 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 with pemetrexed maintenance. Overall intracranial response rate (OIRR) in patients with measurable brain metastases was 57% for patients treated with Zykadia, versus 22% for patients treated with chemotherapy1. The whole body overall response rate (ORR) was 73% in patients treated with Zykadia.