FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
| العنوان: | FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations |
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| المؤلفون: | Katie Chon, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Stephanie Aungst, Emily Wearne, Sriram Subramaniam, Yangbing Li, Jiang Liu, Jielin Sun, Rosane Charlab, Hong Zhao, Banu Saritas-Yildirim, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Julia A. Beaver, Harpreet Singh |
| المصدر: | Clinical Cancer Research. :OF1-OF5 |
| بيانات النشر: | American Association for Cancer Research (AACR), 2023. |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal–epithelial transition receptor, on May 21, 2021, for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Approval was based on results of an ongoing, multicenter, nonrandomized, open-label, multicohort clinical trial (CHRYSALIS, NCT 02609776), demonstrating a substantial overall response rate (ORR) and durable responses, with an ORR of 40% [95% confidence interval (CI): 29–51] and a median response duration of 11.1 months (95% CI: 6.9–not evaluable). Guardant360 CDx was contemporaneously approved as a companion diagnostic for this indication to identify EGFR exon 20 insertion mutations in plasma specimens. The most notable safety finding was the high incidence (66%) of infusion-related reactions, which is addressed in both the Dosage and Administration and Warnings and Precautions sections of the product label. Other common adverse reactions (occurring in ≥20% of patients) were rash, paronychia, musculoskeletal pain, dyspnea, nausea and vomiting, fatigue, edema, stomatitis, cough, and constipation. The approval of amivantamab was the first approval of a targeted therapy for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. |
| تدمد: | 1557-3265 1078-0432 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::4aa0d2c63bf420bc14b2dc7ffe180753 https://doi.org/10.1158/1078-0432.ccr-22-3713 |
| رقم الأكسشن: | edsair.doi...........4aa0d2c63bf420bc14b2dc7ffe180753 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15573265 10780432 |
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