Breakthrough status drives Novartis' Zykadia to early FDA win

The FDA granted an accelerated approval on 29 April to Novartis' Zykadia (ceritinib, LDK378) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small-cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer’s Xalkori (crizotinib).