Approval Summary for Erlotinib for Treatment of Patients with Locally Advanced or Metastatic Non–Small Cell Lung Cancer after Failure of at Least One Prior Chemotherapy Regimen
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- John R. Johnson
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Martin Cohen
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Rajeshwari Sridhara
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Yeh-Fong Chen
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Gene M. Williams
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- John Duan
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Jogarao Gobburu
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Brian Booth
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Kimberly Benson
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- John Leighton
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Li Shan Hsieh
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Nallalerumal Chidambaram
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Paul Zimmerman
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
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- Richard Pazdur
- Authors' Affiliation: Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
抄録
<jats:title>Abstract</jats:title> <jats:p>Purpose: To describe the Food and Drug Administration (FDA) review and approval of erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) for treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.</jats:p> <jats:p>Experimental Design: The FDA reviewed raw data in electronic format from a randomized controlled clinical trial comparing erlotinib with placebo in patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.</jats:p> <jats:p>Results: Patients were randomized in a 2:1 ratio (erlotinib, n = 488 and placebo, n = 243). Erlotinib was superior to placebo for survival, progression-free survival, and tumor response rate. Exploratory analyses indicate that epidermal growth factor receptor status may be an important predictor of the erlotinib survival effect. Rash (75% versus 17%) and diarrhea (54% versus 18%) in the erlotnib and placebo group respectively were the most common adverse events. Severe rash occurred in 9% and severe diarrhea in 6% of erlotinib-treated patients and each resulted in study discontinuation in 1% of patients. Dose reductions were required for 10% of patients with rash and 4% of patients with diarrhea.</jats:p> <jats:p>Conclusions: On November 18, 2004, the FDA granted erlotinib regular approval for treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. The applicant has committed to conduct post-marketing clinical trials to assess further the effect of epidermal growth factor receptor expression, measured with immunohistochemical staining, on erlotinib treatment effect.</jats:p>
収録刊行物
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- Clinical Cancer Research
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Clinical Cancer Research 11 (18), 6414-6421, 2005-09-15
American Association for Cancer Research (AACR)
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詳細情報 詳細情報について
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- CRID
- 1360574094031373184
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- NII論文ID
- 30018691382
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- ISSN
- 15573265
- 10780432
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