▎药明康德内容团队编辑默沙东(MSD)今日宣布,美国FDA已批准其重磅PD-1抑制剂Keytruda(pembrolizumab)与培美曲塞和铂类化疗联合,作为一线疗法治疗不可切除的晚期或转移性恶性胸膜间皮瘤(MPM)成年患者。恶性间皮瘤是一类起源于 ...
美国 FDA 肿瘤药咨询专家委员会于 9 月 26 日以 10 票赞成、2 票反对、1 票弃权的投票结果,决定默沙东的 Keytruda(帕博利珠单抗)和百时美施贵宝(BMS)的 Opdivo(纳武利尤单抗)作为一线治疗药对于生物标志物 PD-L1 检测呈阴性的胃癌患者无效。这一投票结果符合专家会成员、FDA 审评人员和申办人的共识,即当 PD-L1 ...
新泽西州拉威市 - 默沙东集团(在美国和加拿大以外地区称为MSD)的抗PD-1疗法KEYTRUDA(pembrolizumab)获得日本厚生劳动省(MHLW)批准,用于特定肺癌和尿路上皮癌的新适应症。 获批的适应症包括KEYTRUDA联合化疗作为新辅助治疗,随后KEYTRUDA单药作为辅助治疗,用于非小细胞肺癌(NSCLC)患者。这一批准基于KEYNOTE-671三期临床试验结果,该试验显示与化疗 ...
Merck MRK announced data from the phase III KEYFORM-007 study, which evaluated a fixed-dose combination of its anti-LAG-3 antibody, favezelimab and its blockbuster anti-PD-1 therapy, Keytruda in ...
RAHWAY, N.J. - 默沙东集团(在美国和加拿大以外称为MSD)的抗PD-1疗法KEYTRUDA在两项妇科癌症适应症上获得了欧洲药品管理局人用药品委员会(CHMP)的积极意见。CHMP建议批准KEYTRUDA联合化疗用于适合系统治疗的成年原发性晚期或复发性子宫内膜癌患者的一线治疗。此外,CHMP还建议批准KEYTRUDA联合放化疗用于治疗未接受过确定性治疗的成年局部晚期宫颈癌患者。
In particular, Keytruda for cancer represents a key blockbuster with multi-billion-dollar potential: It holds a first-mover advantage in one of the largest cancer indications of non-small cell ...
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved MSD’s anti-programmed death receptor-1 (PD-1) therapy KEYTRUDA (pembrolizumab) for lung and urothelial cancer indications.
默克(MRK.US)周三公布,其实验药物和重磅疗法Keytruda的组合在一项针对先前接受过治疗的结直肠癌患者的後期试验中失败。 该项结直肠癌试验招募了441名患者,其中服用实验药物favezelimab和Keytruda的参与者与接受标准护理治疗的参与者相比,总体生存率没有显着改善。(sw/t) ...
Also Read: Merck’s Keytruda Secures First FDA-Approval For Rare Form Aggressive Cancer. At the final pre-specified analysis, the favezelimab and pembrolizumab fixed-dose combination did not ...
(RTTNews) - Merck (MRK) announced the Japanese Ministry of Health, Labor and Welfare has approved new indications for KEYTRUDA or pembrolizumab, the company's anti-PD-1 therapy, in certain lung ...