Merck's KEYTRUDA Gets Five New Approvals In Japan

默克公司抗癌新药 KEYTRUDA 于日本获5项新批准

2019-01-04 07:21:00 RTTNews


Merck & Co., Inc. (MRK) said that KEYTRUDA, Merck's anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency or PMDA, including three expanded uses in advanced non-small lung cancer or NSCLC, one in melanoma, as well as a new indication in advanced microsatellite instability-high or MSI-H tumors. The new approvals were all granted priority review by the PMDA: KEYTRUDA in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-189); KEYTRUDA in combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of unresectable, advanced/recurrent squamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-407). KEYTRUDA monotherapy in the first-line treatment of PD-L1-positive (Tumor Proportion Score [TPS] =1%) unresectable, advanced/recurrent NSCLC (based on results of the Phase 3 trial KEYNOTE-042); KEYTRUDA monotherapy as adjuvant therapy for melanoma (based on results of the Phase 3 trial EORTC1325/KEYNOTE-054, a study sponsored by Merck and conducted in collaboration with the European Organisation for Research and Treatment of Cancer [EORTC]); and KEYTRUDA monotherapy for the treatment of advanced/recurrent MSI-H solid tumors that have progressed after chemotherapy (only if refractory or intolerant to standard therapies), based on results of two Phase 2 trials, KEYNOTE-164 and KEYNOTE-158. A companion diagnostic to detect MSI-H, the MSI test kit FALCO by FALCO Biosystems Ltd., has also been approved. In addition to the adjuvant therapy approval, dosage and administration for all patients with melanoma has been changed from intravenous infusion of 2 mg/kg (body weight) over 30 minutes at a three-week interval to intravenous infusion of the fixed dose of 200 mg over 30 minutes at a three-week interval. Previously, KEYTRUDA was approved in Japan for the treatment of curatively unresectable melanoma; PD-L1-positive unresectable, advanced or recurrent NSCLC (TPS=1% in second-line setting; TPS=50% in first-line setting); relapsed or refractory classical Hodgkin lymphoma; and curatively unresectable urothelial carcinoma that progressed after chemotherapy. KEYTRUDA is marketed by Merck in Japan and is co-promoted with Taiho Pharmaceutical Co., Ltd.
默克公司( Merck & Co ., Inc .)表示,其抗 PD-1疗法 KEYTRUDA 同时获得了日本药品和医疗器械管理局( PMDA )的5项新批准,其中包括3项用于晚期非小肺癌或非小细胞肺癌( NSCLC )和1项用于黑色素瘤的扩大使用批准,以及MSI-H 肿瘤的新适应症药物批准。 新批准均获得 PMDA 的优先审批:无论 PD-L1表达如何,结合培美曲塞和铂类化疗(顺铂或卡铂),KEYTRUDA可用于不可切除的晚期或复发性非鳞状 NSCLC 一线治疗(基于第III阶段试验 KEYNote-189的结果);结合卡铂、紫杉醇或纳布-紫杉醇,KEYTRUDA可用于不可切除的晚期或复发性鳞状 NSCLC一线治疗。 KEYTRUDA 可单药治疗 PD-L1阳性肿瘤(肿瘤比例分数[ TPS ]=1%)不可切除、晚期/复发性非小细胞肺癌(基于第III期试验结果 KEYNOT-042); 可单药治疗黑色素瘤(基于第III期试验 EORTC1325/ KEYNOT-054的结果)----该临床试验由默克赞助并与欧洲癌症研究和治疗组织( EORTC )合作进行;还能单药治疗化疗后仍有进展的晚期/复发性 MSI-H 实体瘤(仅在不能治愈或不能接受标准疗法的情况下使用)(基于两个II期试验KEYNote-164和 KEYNote-158的数据)由 FALCO Biosystems Ltd .提供的检测 MSI-H 的配套诊断工具 FALCO 也得到批准。 除辅助治疗批准外,所有黑色素瘤患者的剂量和给药方式已从三周间隔30分钟静脉注射2mg / kg (体重),改为三周间隔30分钟静脉注射200mg / kg 固定剂量。以前, KEYTRUDA 在日本被批准用于治疗不可切除的黑色素瘤; PD-L1阳性不可切除晚期或复发性 NSCLC ( TPS =1%在二线设置; TPS =50%在一线设置);复发或难治性经典霍奇金淋巴瘤;以及治疗后仍进展的不可切除的尿路上皮癌。 KEYTRUDA 由默克公司于日本上市,与泰合制药公司共同推广。