Novartis submits LDK378 app in U.S.

Novartis AG (NYSE:NVS; SIX:NOVN) reported its 4Q13 and 2013 earnings on Wednesday and disclosed that in 4Q13 it submitted a regulatory application to FDA for LDK378 to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The company could not be reached for details. The oral small molecule ALK inhibitor is in Phase III testing and has breakthrough therapy designation from FDA for ALK-positive NSCLC in patients who have progressed on or who are intolerant to Xalkori crizotinib from Pfizer Inc. (NYSE:PFE). Novartis expects a decision on the application this half. ...