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FDA Approves Alectinib for ALK-Positive NSCLC

Silas Inman @silasinman
Published: Friday, Dec 11, 2015

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has granted an accelerated approval to alectinib (Alecensa) as a treatment for patients with metastatic ALK-positive non—small cell lung cancer (NSCLC) following progression on crizotinib (Xalkori), based on objective response rates (ORR) in two phase II clinical trials.

References

  1. Gandhi L, Shaw AT, Gadgeel SM, et al. A phase II, open-label, multicenter study of the ALK inhibitor alectinib in an ALK+ non-small-cell lung cancer (NSCLC) U.S./Canadian population who had progressed on crizotinib (NP28761). J Clin Oncol. 2015;33 (suppl; abstr 8019).
  2. Ou S-HI, Ahn JS, Petris LD, et al. Alectinib in Crizotinib-Refractory ALK-Rearranged Non—Small-Cell Lung Cancer: A Phase II Global Study [Published online November 23, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.63.9443

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