AbbVie has secured UK marketing authorisation for ELAHERE (mirvetuximab soravtansine), the first antibody-drug conjugate (ADC) approved in the country for treating folate receptor-alpha (FRα) high, platinum-resistant ovarian cancer.

艾伯维已获得ELAHERE（mirvetuximab soravtansine）在英国的上市许可，这是该国首个获准用于治疗叶酸受体α（FRα）高表达、铂类耐药卵巢癌的抗体药物偶联物（ADC）。

The authorisation, granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA), covers use of the drug as a monotherapy in adults with FRα-high, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, following one to three prior lines of systemic treatment..

英国药品和健康产品管理局（MHRA）授予的授权涵盖了该药物在FRα高表达、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者中的单药治疗使用，适用于既往接受过一至三线系统治疗的情况。

Mirvetuximab soravtansine is the first new treatment to be licensed in the UK for this indication in over a decade.

Mirvetuximab soravtansine 是十多年来英国首个获准用于此适应症的新疗法。

“This is a milestone for the treatment of eligible adult women with folate-receptor high platinum-resistant ovarian cancer in the UK,” said Professor Susana Banerjee, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and Reader in Women’s Cancers at The Institute of Cancer Research, London.

“这是英国治疗叶酸受体高铂类耐药卵巢癌合格成年女性的一个里程碑，”皇家马斯登 NHS 基金会信托基金的医学肿瘤学顾问、伦敦癌症研究所女性癌症学科的苏珊娜·班纳吉教授表示。

“Treatment advances with novel mechanisms of action, like mirvetuximab soravtansine, are crucial for helping eligible women with this type of cancer.”.

“像米伐木肽索拉坦辛这样的具有新颖作用机制的治疗进展，对于帮助符合条件的患有此类癌症的女性至关重要。”

Ovarian cancer is one of the leading causes of death from gynaecological cancer worldwide. In the UK, there are around 7,500 new diagnoses each year, making it the sixth most common cancer in women. Standard treatment typically involves surgery followed by platinum-based chemotherapy, but around 80% of patients with advanced disease relapse.

卵巢癌是全球妇科癌症死亡的主要原因之一。在英国，每年大约有7500例新诊断病例，使其成为女性第六大常见癌症。标准治疗通常包括手术后进行以铂类为基础的化疗，但约80%的晚期患者会复发。

Most eventually develop resistance to platinum therapy..

大多数最终会对铂类治疗产生耐药性。

ELAHERE is administered once every three weeks and is the first new treatment licensed in the UK in over a decade for women with platinum-resistant ovarian cancer. The targeted ADC delivers a cytotoxic payload directly to FRα-expressing tumour cells, aiming to minimise damage to healthy tissues.

ELAHERE每三周给药一次，是英国十多年来首个获准用于治疗铂耐药卵巢癌女性的新型疗法。这种靶向ADC将细胞毒性载荷直接递送至表达FRα的肿瘤细胞，旨在尽量减少对健康组织的损害。

The MHRA’s decision was supported by data from the MIRASOL trial, a global Phase 3, open-label, randomised controlled study that evaluated mirvetuximab soravtansine in patients with FRα-high, platinum-resistant ovarian cancer. Results from the study showed that median progression-free survival (PFS) – the trial’s primary endpoint – was 5.62 months in the mirvetuximab group compared to 3.98 months in the chemotherapy group.

英国药品和健康产品管理局的决定得到了MIRASOL试验数据的支持，这是一项全球性的三期、开放标签、随机对照研究，评估了mirvetuximab soravtansine在FRα高表达、铂类耐药卵巢癌患者中的效果。研究表明，主要终点中位无进展生存期（PFS）在mirvetuximab组为5.62个月，而化疗组为3.98个月。

This translated to a 35% reduction in the risk of disease progression or death..

这相当于将疾病进展或死亡的风险降低了35%。

“AbbVie has an established portfolio of licensed therapies across blood cancers, and today’s announcement marks our broader commitment to support treatment outcomes for patients with solid tumours,” said Rachael Millward, Medical Director, AbbVie UK. “This is an important development for women with advanced ovarian cancer, and in particular, the underserved platinum-resistant patient population.

“AbbVie在血癌领域已有成熟的授权治疗药物组合，而今天的公告标志着我们对支持实体瘤患者治疗结果的更广泛承诺，”AbbVie英国医学总监拉谢尔·米尔沃德表示。“这对晚期卵巢癌女性患者而言是一个重要的进展，特别是对于未得到充分服务的铂类耐药患者群体。”

Following marketing authorisation, our priority now is to work with NICE to provide all the necessary information for their appraisal of mirvetuximab soravtansine.”.

在获得上市许可后，我们现在的优先事项是与NICE合作，提供所有必要的信息以供他们对mirvetuximab soravtansine进行评估。