Keytruda, Lenvima combo gets FDA breakthrough designation for unresectable HCC

默沙东Keytruda联合卫材Lenvima治疗不可切除肝细胞癌获FDA突破性疗法认定

2019-07-26 11:33:00 PHARMACEUTICAL

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The breakthrough therapy designation for the Keytruda, Lenvima combo is for the first-line treatment of patients with advanced unresectable HCC that is not responsive to locoregional treatment. Keytruda is an anti-PD-1 therapy, which has been approved for multiple indications by the FDA, while Lenvima is an orally available kinase inhibitor discovered by Eisai. The kinase inhibitor was approved by the FDA in August 2018 as the first-line treatment for patients with unresectable HCC. Lenvima blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Eisai vice president and oncology business group chief medicine creation and chief discovery officer Takashi Owa said: “We are excited that the FDA has recognized the potential of Keytruda plus Lenvima in combination in advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment with this Breakthrough Therapy designation. “We are dedicated to working together with Merck to potentially bring another important option to patients.” In March 2018, Merck and Eisai formed an oncology collaboration to jointly develop and commercialise Lenvima as a monotherapy and also in combination with Keytruda for the treatment of various types of cancer. The combination of the two drugs already has two FDA breakthrough therapy designations, which are for advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma. The third breakthrough therapy designation has been granted based on the results of the interim results from a phase 1b trial, called KEYNOTE-524/Study 116. Merck Research Laboratories oncology clinical research vice president Jonathan Cheng said: “As part of our ongoing collaboration with Eisai, we are committed to evaluating the potential of Keytruda plus Lenvima across a number of different types of cancer. “With this Breakthrough Therapy designation from the FDA, we look forward to working with Eisai to potentially build upon our existing indications for this difficult-to-treat cancer, so that we can help patients through a combination approach.”
对可瑞达(Keytruda), Lenvima combo 的突破性治疗指定用于一线治疗晚期不可切除 HCC 患者,对局部治疗无效。 可瑞达(Keytruda)是一种抗 PD-1疗法,已被 FDA 批准用于多种适应症,而 Lenvima 是卫材(Eisai)发现的口服激酶抑制剂。激酶抑制剂于2018年8月获得 FDA 批准,成为不可切除 HCC 患者的一线治疗药物。 Lenvima 阻断血管内皮生长因子( VEGF )受体 VEGFR1( FLT1)、 VEGFR2( KDR )和 VEGFR3( FLT4)的激酶活性。 卫材(Eisai)副总裁兼肿瘤业务集团首席药物创制和首席发现官 Takashi Owa 表示:“我们很高兴 FDA 已经认识到可瑞达(Keytruda)和 Lenvima 联合应用于晚期不可切除的肝癌的潜力,而这种突破性的治疗指定不适合用于定位治疗。 “我们致力于与默克(Merck)合作,为患者带来另一个重要的选择。” 2018年3月,默克(Merck)与卫材(Eisai)形成肿瘤合作,共同开发和商业化 Lenvima 作为单一治疗药物,并与可瑞达(Keytruda)联合用于治疗各类癌症。 这两种药物的组合已经有两个 FDA 突破性治疗指定,分别用于晚期和/或转移性肾细胞癌和晚期和/或转移性非微卫星不稳定性高( MSI-H )/熟练错配修复( pMMR )子宫内膜癌。 第三次突破性治疗指定是根据1b 期试验的中期结果授予的,称为 KEYNote-524/ Study 116。 默克(Merck)研究实验室肿瘤临床研究副总裁 JonathanCheng 表示:“作为我们与卫材(Eisai)持续合作的一部分,我们致力于评估可瑞达(Keytruda)和 Lenvima 在多种不同类型癌症中的潜力。 “在 FDA 指定这项突破性治疗方案后,我们期待着与卫材(Eisai)合作,在现有的适应症基础上,进一步开发这一难以治疗的癌症,以便我们能够通过联合治疗的方式帮助患者。”

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