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，安斯泰萊製藥(adr)的安福託莫汀聯合帕博利注射液將成爲提供替代鉑金化療，即目前對於無法手術切除或轉移的膀胱上皮腫瘤患者的標準治療唯一的治療方式。
- 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臨床試驗結果顯示，安福託莫汀聯合帕博利注射液的中位總生存期幾乎比鉑金化療翻了一倍，基於這樣的結果，意見是積極的。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，東京 / PRNewswire / - 安斯泰萊製藥股份有限公司（TSE：4503，總裁兼首席執行官：岡村直樹“安斯泰萊”）今天宣佈，歐洲藥品管理局（EMA）的人用藥品委員會（CHMP）已經通過積極意見，推薦批准PADCEV（enfortumab vedotin，抗體藥物偶聯物[ADC]）與KEYTRUDA（pembrolizumab，PD-1抑制劑）聯合用於不可手術或轉移性的膀胱上皮癌成人患者一線治療，這些患者適合劑量含鉑化療。2