Astellas Receives Positive CHMP Opinion For PADCEV In Combination With KEYTRUDA For First-Line Treatment Of Advanced Bladder Cancer
Astellas Receives Positive CHMP Opinion For PADCEV In Combination With KEYTRUDA For First-Line Treatment Of Advanced Bladder Cancer
- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer
如果批准，安斯泰莱制药(adr)的安福托莫汀联合帕博利注射液将成为提供替代铂金化疗，即目前对于无法手术切除或转移的膀胱上皮肿瘤患者的标准治疗唯一的治疗方式。
- Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy1
- EV-302临床试验结果显示，安福托莫汀联合帕博利注射液的中位总生存期几乎比铂金化疗翻了一倍，基于这样的结果，意见是积极的。1
TOKYO, July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEV (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.2
2024年7月26日，东京 / PRNewswire / - 安斯泰莱制药股份有限公司（TSE：4503，总裁兼首席执行官：冈村直树“安斯泰莱”）今天宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）已经通过积极意见，推荐批准PADCEV（enfortumab vedotin，抗体药物偶联物[ADC]）与KEYTRUDA（pembrolizumab，PD-1抑制剂）联合用于不可手术或转移性的膀胱上皮癌成人患者一线治疗，这些患者适合剂量含铂化疗。2