FDA grants regular approval to Novartis' Zykadia for first-line NSCLC

FDA granted regular approval to Zykadia ceritinib (LDK378) from Novartis AG (NYSE:NVS; SIX:NOVN) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in anaplastic lymphoma kinase (ALK)-positive patients.

The small molecule ALK inhibitor had accelerated approval since 2014 to treat ALK-positive, metastatic NSCLC in patients who progressed on or are intolerant to Xalkori crizotinib (see BioCentury, May 5, 2014)...