Elevar Therapeutics 用于治疗肝细胞癌 (HCC) 的 Rivoceranib 获得 FDA

StephenW

Elevar Therapeutics 用于治疗肝细胞癌 (HCC) 的 Rivoceranib 获得 FDA 的孤儿药指定
2021 年 11 月 12 日，星期五，凌晨 2 点·4 分钟阅读

盐湖城，2021 年 11 月 11 日/美通社/ -- Elevar Therapeutics, Inc.（“Elevar”）是一家完全整合的生物制药公司，致力于为治疗选择有限或不足的患者提升治疗体验和结果，今天宣布，美国食品和药物管理局 (FDA) 已授予 rivoceranib 孤儿药指定用于治疗肝细胞癌 (HCC)。 HCC 是最常见的原发性肝脏恶性肿瘤，是全球癌症相关死亡的主要原因。
Elevar Therapeutics (PRNewsfoto/Elevar Therapeutics)
Elevar Therapeutics (PRNewsfoto/Elevar Therapeutics)

Elevar Therapeutics 首席执行官 Kate McKinley 表示：“ FDA 授予的孤儿药称号承认 rivoceranib 有潜力解决对新疗法的迫切未满足需求，这些新疗法可以改善 HCC 患者的治疗效果。 “医学界渴望看到探索 HCC 新联合方案的临床试验的结果，我们期待迅速推进我们的 rivoceranib 和 camrelizumab（一种研究性 PD-L1 抑制剂）的临床试验。这项 3 期试验正在合作进行与江苏恒瑞医药有限公司合作，针对既往未接受过全身治疗的晚期 HCC 患者。除了我们的 HCC 项目外，我们还致力于加速 rivoceranib 作为治疗胃癌的潜在疗法的临床开发，腺样囊性癌和结直肠癌。”

HCC 是一种高度致命的肝癌形式，治疗选择有限，主要由乙型肝炎病毒 (HBV) 或丙型肝炎病毒 (HCV) 慢性感染、非酒精性脂肪性肝炎 (NASH) 和过量饮酒引起。

Elevar Therapeutics 的首席医疗官、F.A.C.P. 医学博士 Maureen G. Conlan 说：“不幸的是，HCC 通常在疾病晚期才被诊断出来，目前可用的治疗选择有限。” “我们对我们在 3 期临床试验中取得的进展感到鼓舞，并相信 rivoceranib 和 camrelizumab 的组合如果获得批准，将为临床医生和患者提供一个重要的新治疗选择。”

FDA 的孤儿药产品办公室授予孤儿药地位，用于治疗服务不足的患者群体或罕见疾病，在美国影响不到 200,000 人的孤儿药项目获得临床试验支出的部分税收抵免，免除用户申请费和潜在的获得批准后七年的营销专营权。

关于 Rivoceranib（阿帕替尼）
Rivoceranib 是第一个在中国获批用于胃癌的小分子酪氨酸激酶抑制剂 (TKI)，名称为阿帕替尼（2014 年 12 月）。 Rivoceranib 是血管内皮生长因子受体 2 (VEGFR-2) 的高效抑制剂，VEGFR-2 是肿瘤血管生成的主要途径。 VEGFR-2 抑制是一种经过临床验证的限制肿瘤生长和疾病进展的方法。阿帕替尼已在全球超过 1,000 名患者中进行了研究，并且在临床试验中具有良好的耐受性，其安全性与其他 TKI 和 VEGF 抑制剂相当。 Rivoceranib 目前正在研究作为单一疗法以及与化学疗法和免疫疗法联合使用。

多种肿瘤类型的临床研究正在进行中，包括胃癌（作为单一疗法并与紫杉醇联合）、肝细胞癌（与 camrelizumab 联合）、腺样囊性癌和结直肠癌（与 Lonsurf®联合）。孤儿药指定已被授予治疗胃癌（美国、欧盟和韩国）、腺样囊性癌（美国）和肝细胞癌（美国）的药物。 Elevar Therapeutics 拥有全球权利（不包括中国），并已在韩国与 HLB-LS 合作开发和营销 rivoceranib。阿帕替尼目前在中国获得中国领土许可持有者江苏恒瑞医药有限公司的批准，用于治疗晚期胃癌和二线晚期 HCC，品牌名称为 Aitan®。
關於 Elevar Therapeutics
Elevar Therapeutics 是一家快速發展、完全整合的生物製藥公司，其建立在為治療選擇有限或不足的患者提升治療體驗和結果的承諾之上。 Elevar 的主要專有候選藥物包括 rivoceranib（阿帕替尼）和 Apealea®（紫杉醇膠束）。 Rivoceranib在中國以阿帕替尼為名，由中國恆瑞研發，2014年在中國獲批用於治療胃癌的單藥，2020年獲批用於二線晚期HCC，在美國獲得孤兒藥資格認定，歐洲和韓國，並已在全球 1,000 多名患者中進行了多種癌症適應症的臨床測試。 Apealea®（紫杉醇膠束）是一種非 Cremophor EL 紫杉醇製劑，於 2018 年 11 月獲得歐盟委員會的上市許可，使其成為歐洲首個獲准用於卵巢癌的非 Cremophor EL 紫杉醇製劑。 Elevar Therapeutics 在猶他州、加利福尼亞州、愛爾蘭和韓國設有辦事處。如需更多信息，請訪問 www.elevartherapeutics.com/。

Elevar 媒體聯繫人：
Elixir Health 公共關係
林賽·羅科
+1 862-596-1304
[email protected]

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消息來源 Elevar Therapeutics

StephenW

Elevar Therapeutics Receives Orphan Drug Designation from FDA for Rivoceranib for the Treatment of Hepatocellular Carcinoma (HCC)
Fri, November 12, 2021, 2:00 AM·4 min read

SALT LAKE CITY, Nov. 11, 2021 /PRNewswire/ -- Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S. Food and Drug Administration (FDA) has granted rivoceranib with orphan drug designation for the treatment of hepatocellular carcinoma (HCC). HCC is the most common primary liver malignancy and is a leading cause of cancer-related death worldwide.
Elevar Therapeutics (PRNewsfoto/Elevar Therapeutics)
Elevar Therapeutics (PRNewsfoto/Elevar Therapeutics)

"The orphan drug designation granted by the FDA recognizes the potential of rivoceranib to address the urgent unmet need for new therapies that can improve patient outcomes for people with HCC," said Kate McKinley, Chief Executive Officer of Elevar Therapeutics. "The medical community is eager to see the results of clinical trials exploring new combination regimens in HCC and we look forward to rapidly advancing our clinical trial of rivoceranib and camrelizumab, an investigational PD-L1 inhibitor. This Phase 3 trial is being conducted in collaboration with Jiangsu Hengrui Medicine Company, Ltd., in patients with advanced HCC who have not received prior systemic therapy. In addition to our HCC program, we are committed to accelerating the clinical development for rivoceranib as a potential therapy for the treatment of gastric cancer, adenoid cystic carcinoma, and colorectal cancer."

HCC is a highly lethal form of liver cancer with limited treatment options, which is primarily caused by chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), nonalcoholic steatohepatitis (NASH), and excessive alcohol consumption.

"Unfortunately, HCC is often diagnosed at later stages of disease and there are limited treatment options currently available," said Maureen G. Conlan, M.D., F.A.C.P., Chief Medical Officer of Elevar Therapeutics. "We are encouraged by the progress that we are making in our Phase 3 clinical trial and believe that the combination of rivoceranib and camrelizumab, if approved, will offer an important new therapeutic option for clinicians and patients."

The FDA's Office of Orphan Drug Products grants orphan status to medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user filing fees and potential eligibility for seven years of marketing exclusivity post-approval.

About Rivoceranib (apatinib)
Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer, under the name apatinib, in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Apatinib has been studied in over 1,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy.

Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma, and colorectal cancer (combination with Lonsurf®). Orphan Drug designations have been granted in gastric cancer (U.S., EU, and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar Therapeutics holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd under the brand name Aitan®.
About Elevar Therapeutics
Elevar Therapeutics is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar's lead proprietary drug candidates include rivoceranib (apatinib) and Apealea® (paclitaxel micellar). Rivoceranib, under the name apatinib in China, was developed by Hengrui in China and approved in China as a single agent for treatment of gastric cancer in 2014 and second-line advanced HCC in 2020. It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide in numerous cancer indications. Apealea® (paclitaxel micellar) is a non-Cremophor EL based formulation of paclitaxel that received marketing authorization by the European Commission in November 2018, making it Europe's first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has offices in Utah, California, Ireland, and South Korea. Additional information is available at www.elevartherapeutics.com/.

Elevar Media Contact:
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
[email protected]

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SOURCE Elevar Therapeutics

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