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FDA授予阿斯利康肿瘤免疫疗法tremelimumab孤儿药地位

新药编辑:新特药 更新时间:2015-04-18

2015年4月15日讯 /tumor.net.cn/ --英国制药巨头阿斯利康(AZN)肿瘤学管线近日收获了一个孤儿药地位,FDA已授予肿瘤免疫疗法tremelimumab治疗恶性间皮瘤(malignant mesothelioma,MM)的孤儿药地位。

间皮瘤是一种罕见的恶性肿瘤,预后极差,通常是由于接触石棉(asbestos)所致,最常影响肺和腹腔的衬里(lining),该病治疗选择非常有限,尤其是晚期疾病患者。目前,间皮瘤的5年生存率少于百分之五,甚至当疾病得到及时诊断和治疗时也是如此,大多数患者在确诊后一年内死亡。tremelimumab有望为该患者群体提供一种潜在的新治疗选择。

tremelimumab是一种抗细胞毒性T淋巴细胞抗原4(CTLA-4)全人源化单克隆抗体,能够阻断帮助肿瘤逃避免疫检查的信号通路。tremelimumab通过结合表达于活化的T淋巴细胞表面的CTLA-4蛋白,刺激机体免疫系统对肿瘤细胞发起攻击。

值得一提的是,百时美施贵宝的肿瘤免疫疗法Yervoy(ipilimumab,易普利姆玛)与tremelimumab同属于抗CTLA-4单抗,Yervoy已于2011年获FDA批准上市,用于晚期转移性黑色素瘤的治疗。

除了作为间皮瘤的一种单药疗法,目前阿斯利康正在多种类型肿瘤中探索tremelimumab与PD-L1免疫疗法MEDI4376组合的临床潜力,包括非小细胞肺癌(NSCLC)、头颈部癌症等。此外,阿斯利康也正在调查tremelimumab联合易瑞沙(Iressa)治疗EGFR突变型NSCLC,以及联合MEDI6469(一种小鼠OX40激动剂)治疗多种实体瘤。(tumor.net.cn)

英文原文:Tremelimumab granted Orphan Drug Designation by US FDA for treatment of malignant mesothelioma

Wednesday, 15 April 2015

AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma.

Mesothelioma is a rare, aggressive cancer that most often affects the lining of the lungs and abdomen. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease.

“There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care. Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients,” said Robert Iannone, Senior Vice President, Head of Immuno-oncology, Global Medicines Development at AstraZeneca.

The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US1.

Tremelimumab is part of the broad pipeline of immuno-oncology assets being developed by AstraZeneca and its biologics research and development arm, MedImmune, which are designed to harness the body’s own immune system to fight cancer. It is a fully human monoclonal antibody, which stimulates the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes.

In addition to being investigated as a monotherapy treatment for patients with mesothelioma, tremelimumab is currently being studied in combination with AstraZeneca’s anti PD-L1 investigational immunotherapy, MEDI4736, in tumour types including non-small cell lung cancer and head and neck cancer. It is also being studied in combination with Iressa (gefitinib) in EGFR mutated non-small cell lung cancer and with MEDI6469 (a murine OX40 agonist) in solid tumours.

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