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FDA expands Zykadia's label to first-line NSCLC

May 26, 2017 9:58 PM UTC

FDA granted regular approval to Zykadia ceritinib from Novartis AG (NYSE:NVS; SIX:NOVN) for the first-line treatment of metastatic non-small cell lung cancer in anaplastic lymphoma kinase (ALK)-positive patients. The small molecule ALK inhibitor had accelerated approval to treat ALK-positive, metastatic NSCLC in patients who progressed on or are intolerant to Xalkori crizotinib.

The agency based its approval on the Phase III ASCEND-4 trial, in which oral Zykadia significantly improved median progression-free survival (PFS) vs. chemotherapy (16.6 vs. 8.1 months, HR=0.55, 95% CI: 0.42, 0.73, one-sided p<0.0001). Zykadia also led to a confirmed objective response rate (ORR) of 73% vs. 27% for chemotherapy...