Novartis AG (NVS) said Tuesday that the US Food and Drug Administration has approved Zykadia for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.
The approval of Zykadia was based on a pivotal trial that included 163 patients with metastatic ALK+ NSCLC who progressed on or were intolerant to treatment with crizotinib. The most common sites of metastases in the patient population studied were brain, liver and bone.
Among previously-treated patients, Zykadia achieved an overall response rate of 54.6% and a median duration of response of 7.4 months.
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