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CCR Drug Updates

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer

Sean Khozin, Chana Weinstock, Gideon M. Blumenthal, Joyce Cheng, Kun He, Luning Zhuang, Hong Zhao, Rosane Charlab, Ingrid Fan, Patricia Keegan and Richard Pazdur
Sean Khozin
U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • For correspondence: Sean.Khozin@fda.hhs.gov
Chana Weinstock
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Gideon M. Blumenthal
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Joyce Cheng
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Kun He
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Luning Zhuang
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Hong Zhao
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Rosane Charlab
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Ingrid Fan
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Patricia Keegan
U.S. Food and Drug Administration, Silver Spring, Maryland.
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Richard Pazdur
U.S. Food and Drug Administration, Silver Spring, Maryland.
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DOI: 10.1158/1078-0432.CCR-16-1773
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Abstract

On November 13, 2015, the FDA granted accelerated approval to osimertinib (TAGRISSO; AstraZeneca), a breakthrough therapy-designated drug for the treatment of patients with metastatic EGFR T790M mutation–positive non–small cell lung cancer, as detected by an FDA-approved test, with progression on or after EGFR tyrosine kinase inhibitor therapy. Approval was based on durable tumor response rates in two single-arm, multicenter trials: the dose extension cohort of a first-in-human trial (FIH; AURA extension; n = 201) and a fixed-dose, activity-estimating trial (AURA2; n = 210). Osimertinib was administered at 80 mg orally once daily. The objective response rates (ORR) per blinded independent committee review were 57% [95% confidence interval (CI), 50–64) in AURA extension and 61% (95% CI, 54–68) in AURA2. Median duration of response (DOR) could not be estimated. Supportive efficacy data from 63 patients in the dose-finding part of the FIH trial demonstrated an ORR of 51% (95% CI, 38–64), with a median DOR of 12.4 months. Common adverse events (AE) evaluated in 411 patients included diarrhea (42%), rash (41%), dry skin (31%), and nail toxicity (25%). Grade 3 to 4 AEs occurred in 28% of patients, and 5.6% discontinued treatment due to AEs. Clin Cancer Res; 23(9); 1–5. ©2016 AACR.

  • Received July 13, 2016.
  • Revision received October 4, 2016.
  • Accepted October 8, 2016.
  • ©2016 American Association for Cancer Research.
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Published OnlineFirst April 11, 2017
doi: 10.1158/1078-0432.CCR-16-1773

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Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer
Sean Khozin, Chana Weinstock, Gideon M. Blumenthal, Joyce Cheng, Kun He, Luning Zhuang, Hong Zhao, Rosane Charlab, Ingrid Fan, Patricia Keegan and Richard Pazdur
Clin Cancer Res April 11 2017 DOI: 10.1158/1078-0432.CCR-16-1773

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Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer
Sean Khozin, Chana Weinstock, Gideon M. Blumenthal, Joyce Cheng, Kun He, Luning Zhuang, Hong Zhao, Rosane Charlab, Ingrid Fan, Patricia Keegan and Richard Pazdur
Clin Cancer Res April 11 2017 DOI: 10.1158/1078-0432.CCR-16-1773
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Clinical Cancer Research
eISSN: 1557-3265
ISSN: 1078-0432

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