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FDA Grants Crizotinib Breakthrough Designation for MET+ NSCLC and ALK+ ALCL

Jason M. Broderick @jasoncology
Published: Tuesday, May 29, 2018

Dr. Mace Rothenberg

Mace Rothenberg, MD
The FDA has granted crizotinib (Xalkori) a breakthrough therapy designation for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with MET exon 14 alterations who progress after receiving platinum-based chemotherapy. The agency also granted the designation to the kinase inhibitor for use in patients with relapsed/refractory ALK+ anaplastic large cell lymphoma (ALCL).

The most frequently reported all-grade AE in the ALCL groups was a decrease in neutrophil count, which occurred in 33% of patients receiving the lower dose and 70% of patients receiving the higher dose.


  1. Drilon AE, Camidge DR, Ou S-H, et al. Efficacy and safety of crizotinib in patients (PTS) with advanced MET exon 14-altered non-small cell lung cancer (NSCLC). J Clin Oncol 2016 34:15_suppl, 108-108.
  2. Gambacorti-Passerini C, Orlov S, Zhang L, et al. Long-term effects of crizotinib in ALK-positive tumors (excluding NSCLC): a phase 1b open-label study. Am J Hematol. 2018;93:607-614. doi: 10.1002/ajh.25043.
  3. Mossé YP, Voss SD, Lim MS, et al. Targeting ALK with crizotinib in pediatric anaplastic large cell lymphoma and inflammatory myofibroblastic tumor: a Children's Oncology Group study. J Clin Oncol. 2017 Oct 1;35(28):3215-3221. doi: 10.1200/JCO.2017.73.4830.

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