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FDA Approves Ceritinib for ALK-Positive NSCLC

Silas Inman @silasinman
Published: Tuesday, Apr 29, 2014

Dr. Richard Pazdur

Richard Pazdur, MD

Acting 4 months ahead of schedule, the FDA has granted an accelerated approval to ceritinib (Zykadia; LDK378) as a treatment for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) following treatment with crizotinib (Xalkori), based on a single-arm clinical trial demonstrating a durable improvement in overall response rates (ORR).
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