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US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer.
Akinboro, Oladimeji; Drezner, Nicole; Amatya, Anup; Runyan, Jin; Fourie-Zirkelbach, Jeanne; Zhao, Miao; Bi, Youwei; Korsah, Kwadwo; Mixter, Bronwyn; Tang, Shenghui; Larkins, Erin; Pazdur, Richard; Beaver, Julia A; Singh, Harpreet.
Afiliação
  • Akinboro O; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Drezner N; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Amatya A; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Runyan J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Fourie-Zirkelbach J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Zhao M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Bi Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Korsah K; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Mixter B; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD.
  • Tang S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Larkins E; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Pazdur R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
  • Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD.
  • Singh H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.
J Clin Oncol ; 41(17): 3249-3259, 2023 06 10.
Article em En | MEDLINE | ID: mdl-37141544
ABSTRACT

PURPOSE:

On March 4, 2022, the US Food and Drug Administration (FDA) approved nivolumab plus platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable non-small-cell lung cancer (NSCLC). We discuss the FDA's review of the key data and regulatory considerations supporting this approval. PATIENTS AND

METHODS:

The approval was based on the results of CheckMate 816, an international, multiregional, active-controlled trial that randomly assigned 358 patients with resectable NSCLC, stage IB (≥4 cm) to IIIA (N2) per the American Joint Committee on Cancer seventh staging edition to receive either nivolumab plus platinum-doublet or platinum-doublet chemotherapy alone for three cycles before planned surgical resection. The major efficacy end point that supported this approval was event-free survival (EFS).

RESULTS:

At the first planned interim analysis (IA), the hazard ratio (HR) for EFS was 0.63 (95% CI, 0.45 to 0.87; P = .0052; statistical significance boundary = .0262) favoring the nivolumab plus chemotherapy arm; the median EFS was 31.6 months (95% CI, 30.2 to not reached) in the nivolumab plus chemotherapy arm versus 20.8 months (95% CI, 14.0 to 26.7) in the chemotherapy-only arm. At the time of a prespecified IA for overall survival (OS), 26% of patients had died, and the HR for OS was 0.57 (95% CI, 0.38 to 0.87; P = .0079; statistical significance boundary = .0033). Eighty-three percent of patients in the nivolumab-containing arm versus 75% in the chemotherapy-only arm received definitive surgery.

CONCLUSION:

This approval, the first for any regimen for the neoadjuvant treatment of NSCLC in the United States, was supported by a statistically significant and clinically meaningful improvement in EFS with no evidence of detriment in OS or negative impact on patients' receipt and timing of surgery or surgical outcomes.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2023 Tipo de documento: Article