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Novartis' ALK inhibitor gets FDA breakthrough designation

March 15, 2013 11:42 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA granted breakthrough drug designation to LDK378 to treat anaplastic lymphoma kinase ( ALK)-positive metastatic non-small cell lung cancer (NSCLC) in patients who have progressed or who are intolerant to crizotinib. The oral small molecule ALK inhibitor is in Phase II testing for the indication, with Phase III testing slated to start this year. Novartis said it plans to submit regulatory applications for LDK378 in early 2014. Pfizer Inc. (NYSE:PFE) markets Xalkori crizotinib. ...