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Breakthrough status drives Novartis' Zykadia to early FDA win

 
• By Donna Young

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).

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).

Novartis' medicine is the first drug to treat that population, the company said.

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