FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer.

Autor:	Singh S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. sonia.singh@fda.hhs.gov., Jaigirdar AA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mulkey F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Cheng J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hamed SS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhao H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Goheer A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Helms WS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Agarwal R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pragani R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Korsah K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Leighton J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Rahman A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 May 01; Vol. 27 (9), pp. 2378-2382. Date of Electronic Publication: 2020 Dec 07.
DOI:	10.1158/1078-0432.CCR-20-3901
Abstrakt:	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. (©2020 American Association for Cancer Research.)
Databáze:	MEDLINE
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