Breakthrough status drives Novartis' Zykadia to early FDA win
This article was originally published in Scrip
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).
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