U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
| Autor: | Xianhua Cao, Marc R. Theoret, Meredith Libeg, Liang Zhao, Whitney S. Helms, Kun He, Laurie Graham, Richard Pazdur, Meredith K. Chuk, Hongshan Li, Joel T. Welch, Hong Zhao, Maitreyee Hazarika, Rajeshwari Sridhara, Alexander H. Putman, Sirisha Mushti, Shawna L. Weis, Patricia Keegan |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Proto-Oncogene Proteins B-raf 0301 basic medicine Oncology Cancer Research medicine.medical_specialty Metastatic melanoma Ipilimumab Disease-Free Survival law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Humans Neoplasm Metastasis Melanoma Protein Kinase Inhibitors Aged United States Food and Drug Administration business.industry Disease progression Antibodies Monoclonal Cancer Middle Aged medicine.disease United States Confidence interval Surgery Clinical trial Nivolumab 030104 developmental biology 030220 oncology & carcinogenesis Mutation Disease Progression Female business medicine.drug |
| Zdroj: | Clinical Cancer Research. 23:3484-3488 |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks with at least 6-month follow-up in an ongoing, randomized, open-label, active-controlled clinical trial. The ORR as assessed by a blinded independent review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5–40.8). Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ to 10+ months. In 13 patients, the response duration was 6 months or longer. The risks of nivolumab, including clinically significant immune-mediated adverse reactions (imARs), were assessed in 268 patients who received at least one dose of nivolumab. The FDA review considered whether the ORR and durations of responses were reasonably likely to predict clinical benefit, the adequacy of the safety database, and systematic approaches to the identification, description, and patient management for imARs in product labeling. Clin Cancer Res; 23(14); 3484–8. ©2017 AACR. |
| Databáze: | OpenAIRE |
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