2. Trotman J, Buske C, Tedeschi A, Matous JV, et al. Long-Term Follow-up of Ibrutinib Treatment for Rituximab-Refractory Waldenström’s Macroglobulinemia: Final Analysis of the Open-Label Substudy of the Phase 3 iNNOVATE Trial. Presented at: 2020 ASH Annual Meeting; December 5-8, 2020;...
瑞士制药巨头罗氏(Roche)近日宣布,美国食品和药物管理局(FDA)已批准MabThera/Rituxan(品牌名:美罗华,通用名:rituximab,利妥昔单抗)标签更新,纳入接受该药诱导治疗后病情得到控制的肉芽肿性血管炎(GPA)和显微镜下多血管炎(MPA)成人患者的后续治疗信息。在美国,FDA于2011年批准美罗华联合糖皮质激素(GCC)用于GPA和MPA成人...
2. Trotman J, Buske C, Tedeschi A, Matous JV, et al. Long-Term Follow-up of Ibrutinib Treatment for Rituximab-Refractory Waldenström’s Macroglobulinemia: Final Analysis of the Open-Label Substudy of the Phase 3 iNNOVATE Trial. Presented at: 2020 ASH Annual Meeting; December 5-8, 2020;...
儿童淋巴瘤创新疗法Rituximab 2021年12月,美国食品药品管理局(FDA)批准利妥昔单抗(Rituximab)联合化疗用于治疗既往未经治疗的晚期CD20阳性弥漫性大B细胞淋巴瘤(DLBCL)、伯基特淋巴瘤(BL)、伯基特样淋巴瘤(BLL)或成熟B细胞急性白血病(B-AL)儿童(≥6个月并<18岁)的患者。 ▲图源:参考来源[10] 首款用于罕见肉瘤...
4. Joly P, et al. First-Line Rituximab Combinedwith Short-Term Prednisone Versus Prednisone Alone for the Treatment of Pemphigus (Ritux 3): A Prospective, Multicentre, Parallel-Group, Open-LabelRandomised Trial. The Lancet. March 22, 2017...
当地时间 2024 年 3 月 7 日,美国食品药品监督管理局(FDA)官网宣布,布鲁顿氏酪氨酸激酶(BTK)抑制剂百悦泽®(泽布替尼)获得批准,联合奥妥珠单抗用于治疗既往接受过至少两线系统性治疗的复发或难治性(R/R)滤泡性淋巴瘤(FL)成人...
Conclusions The clinical manifestations of ocular AE during MMF treatment are di‑ verse, and none of them are recorded in the drug label. The clinical outcomes are poor and can lead to blind‑ ness, which should be vigilant in clinical practice. 【Key words】 Immunosuppressive agents; Eye...
2. RUXIENCE™ (rituximab-pvvr) Prescribing Information. New York. NY: Pfizer Inc: 2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf. Accessed July 2019. 3. Sharman J, et al. A Randomized, Double-Blind Efficacy and Safety Study of PF-05280...
Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), the first China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (...
The FDA has approved the combination of rituximab plus chemotherapy to treat children aged between 6 months and 18 years who have advanced-stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or