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Cited by 359

The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1

Open access
Sul, Joohee, Blumenthal, Gideon M., Jiang, Xiaoping, He, Kun, Keegan, Patricia, Pazdur, Richard·2016·The Oncologist
DOI 10.1634/theoncologist.2015-0498
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Abstract

On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab, a breakthrough therapy-designated drug, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test, and who have disease progression on or after platinum-containing chemotherapy or targeted therapy against anaplastic lymphoma kinase or epidermal growth factor receptor, if appropriate. This indication was approved concurrently with the PD-L1 immunohistochemistry 22C3 pharmDx, a companion diagnostic test for patient selection based on PD-L1 tumor expression. The accelerated approval was granted based on durable objective response rate (ORR) and an acceptable toxicity profile demonstrated in a multicenter, open-label trial enrolling 550 patients with metastatic NSCLC. The efficacy population comprised 61 patients with tumors identified as strongly positive for PD-L1, and the confirmed ORR as determined by blinded independent central review was 41% (95% confidence interval: 28.6%, 54.3%); all were partial responses. At the time of the analysis, responses were ongoing in 21 of 25 patients (84%), with 11 patients (44%) having response duration of ≥6 months. The most commonly occurring (≥20%) adverse reactions included fatigue, decreased appetite, dyspnea, and cough. The most frequent (≥2%) serious adverse drug reactions were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. Immune-mediated adverse reactions occurred in 13% of patients and included pneumonitis, colitis, hypophysitis, and thyroid disorders. The accelerated approval regulations describe approval of drugs and biologic products for serious and life-threatening illnesses based on a surrogate endpoint likely to predict clinical benefit. Under these regulations, a confirmatory trial or trials is required to verify and describe the benefit of pembrolizumab for patients with metastatic NSCLC.

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Metadata

Authors
Sul, J., Blumenthal, G. M., Jiang, X., He, K., Keegan, P., & Pazdur, R.
Venue
The Oncologist
Publisher
Oxford University Press (OUP)
Published
2016-03-29
Volume
21
Issue
5
Pages
643-650
ISSN
  • 1083-7159 (ISSN-L)
  • 1549-490X
DOI
10.1634/theoncologist.2015-0498
OpenAlex
W2368001341
Cited by
359
References
14
FWCI
21.79
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1. https://app.cochat.ai/papers/10.1634/theoncologist.2015-0498
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Sul, J., Blumenthal, G. M., Jiang, X., He, K., Keegan, P., & Pazdur, R. (2016). FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1. The Oncologist. https://doi.org/10.1634/theoncologist.2015-0498

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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