FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
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- Sonia Singh
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Adnan A. Jaigirdar
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Flora Mulkey
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Joyce Cheng
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Salaheldin S. Hamed
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Yangbing Li
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Jiang Liu
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Hong Zhao
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Anwar Goheer
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Whitney S. Helms
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Xing Wang
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Rajiv Agarwal
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Rajan Pragani
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Kwadwo Korsah
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Shenghui Tang
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- John Leighton
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Atiqur Rahman
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Julia A. Beaver
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Richard Pazdur
- 2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Marc R. Theoret
- 2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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- Harpreet Singh
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
抄録
<jats:title>Abstract</jats:title> <jats:p>On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted on the basis of the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multicohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% [95% confidence interval (CI): 26–45], with a median DOR of 5.3 (95% CI: 4.1–6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.</jats:p>
収録刊行物
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- Clinical Cancer Research
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Clinical Cancer Research 27 (9), 2378-2382, 2020-12-07
American Association for Cancer Research (AACR)