The new approval is based on results from the CheckMate 057 study, conducted in 582 patients with advanced nonsquamous NSCLC who had progressed on platinum-doublet chemotherapy. The overall results showed that median overall survival was about 3 months longer with nivolumab than withdocetaxel(12.2 v...
https://news.bms.com/news/corporate-financial/2021/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-for-the-Adjuvant-Treatment-of-Patients-with-High-Risk-Urothelial-Carcinoma/default.aspx [5] FDA Grants BAVENCIO® (ave...
The FDA based its approval on the results of the CheckMate-142 study, which was recentlypublishedin theLancet Oncology, asreportedbyMedscape Medical News. This was a phase 2, multicenter, open-label, single-arm clinical trial that evaluated nivolumab in 74 patients with locally determined dMMR ...
先前,已经有一款PD-1抑制剂获批。今日的这项批准,也进一步表明肿瘤免疫疗法的潜力。未来,我们期待更多好消息。 参考资料: [1] Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Ox...
2015年11月30日讯 /生物谷BIOON/ --免疫治疗领域的王者——百时美施贵宝(BMS)近日宣布,FDA已批准PD-1免疫疗法Opdivo(nivolumab)作为一种单药疗法,用于BRAF V600野生型(wild-type,WT)不可切除性或转移性黑色素瘤患者的治疗。此次批准,是Opdivo在过去一年(12个月)收获的第6个FDA批准,同时也标志着Opdivo成为PD-...
The recommended doses for metastatic NSCLC are nivolumab 3 mg/kg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity, or up to 2 years in patients without disease progression. More information about the approval is available on theFDA website....
FDA approval sum- mary: nivolumab for the treatment of metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. Oncologist. 2016;21:634-642.Kazandjian, D.; Suzman, D.L.; Blumenthal, G.; Mushti, S.; He, K.; Libeg, M.; Keegan, P.; Pazdur, ...
2022年3月,FDA批准由固定剂量的抗LAG-3抗体药物Relatlimab与抗PD-1抗体Opdivo(nivolumab)联合组成的 “first-in-class”疗法Opdualag,治疗罹患不可切除或转移性黑色素瘤的成人和儿童(12岁及以上)患者。Relatlimab是FDA批准的首款LAG-3抗体,也是近十年来针对全新免疫检查点获批的首款创新癌症免疫疗法。
美国FDA 12月22日加速批准Opdivo (nivolumab)用于治疗无法手术切除或已经出现转移且对其它药物无应答的晚期黑色素瘤患者。 黑色素瘤是美国第5大常见的肿瘤类型。该肿瘤由体内可以形成皮肤色素的黑色素细胞形成。美国国家癌症研究所估计,今年将会有76100 名美国人被诊断为黑色素瘤,9710人将会死于该疾病。
自2000年以来,有五种不同的药物分别获得了12项或更多的批准:三种ICI(pembrolizumab、nivolumab和atezolizumab)、一种抗VEGFR的抗体药物(贝伐单抗)和一种激酶抑制剂(伊马替尼)。除激酶抑制剂和ICI外,还有29种药物类别也为批准的肿瘤学产品格局做出了贡献。抗肿瘤相关抗原(TAA)...