FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond
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- Lee Pai-Scherf
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Gideon M. Blumenthal
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Hongshan Li
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Sriram Subramaniam
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Pallavi S. Mishra-Kalyani
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Kun He
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Hong Zhao
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Jingyu Yu
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Mark Paciga
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Kirsten B. Goldberg
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Amy E. McKee
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Patricia Keegan
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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- Richard Pazdur
- Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
説明
<jats:title>Abstract</jats:title> <jats:p>On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.</jats:p> <jats:p>Approval was based on two randomized, open-label, active-controlled trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE−024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41–0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37–0.68; p < .001). In KEYNOTE-010, patients with disease progression on or after platinum-containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58–0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49–0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy.</jats:p>
収録刊行物
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- The Oncologist
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The Oncologist 22 (11), 1392-1399, 2017-08-23
Oxford University Press (OUP)
