FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.

Autor:	Mathieu LN; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Luckson.Mathieu@fda.hhs.gov., Larkins E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Akinboro O; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Roy P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Amatya AK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mishra-Kalyani PS; 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., Myers CE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Skinner AM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Aungst S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Jin R; 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., Xia H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zirkelbach JF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Bi Y; 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., Grimstein M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Woods S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Reece K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Abukhdeir AM; Center for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Ghosh S; Center for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Philip R; Center for Device and Radiological Health, 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., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; 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., 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., 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] 2022 Jan 15; Vol. 28 (2), pp. 249-254. Date of Electronic Publication: 2021 Aug 03.
DOI:	10.1158/1078-0432.CCR-21-1566
Abstrakt:	The FDA approved capmatinib and tepotinib on May 6, 2020, and February 3, 2021, respectively. Capmatinib is indicated for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Tepotinib is indicated for mNSCLC harboring MET exon 14 skipping alterations. The approvals were based on trials GEOMETRY mono-1 (capmatinib) and VISION (tepotinib). In GEOMETRY mono-1, overall response rate (ORR) per Blinded Independent Review Committee (BIRC) was 68% [95% confidence interval (CI), 48-84] with median duration of response (DoR) 12.6 months (95% CI, 5.5-25.3) in 28 treatment-naïve patients and 41% (95% CI: 29, 53) with median DoR 9.7 months (95% CI, 5.5-13) in 69 previously treated patients with NSCLC with mutations leading to MET exon 14 skipping. In VISION, ORR per BIRC was 43% (95% CI: 32, 56) with median DoR 10.8 months (95% CI, 6.9-not estimable) in 69 treatment-naïve patients and 43% (95% CI, 33-55) with median DoR 11.1 months (95% CI, 9.5-18.5) in 83 previously-treated patients with NSCLC harboring MET exon 14 alterations. These are the first two therapies to be FDA approved specifically for patients with metastatic NSCLC with MET exon 14 skipping. (©2021 American Association for Cancer Research.)
Databáze:	MEDLINE
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