ELAHERE mirvetuximab soravtansine-gynx
Drug Class
Folate receptor alpha (FR-alpha) directed antibody-drug conjugate (ADC)靶向叶酸受体alpha (FR-alpha) 的抗体偶联药物 (ADC)
Mechanism
Binds to FR-alpha on tumor cells and internalizes, releasing DM4, a microtubule inhibitor payload that disrupts mitosis and cell division.特异性结合肿瘤细胞表面的叶酸受体alpha (FR-alpha) 并内吞,在细胞内释放微管蛋白抑制剂 DM4,破坏有丝分裂并导致细胞死亡。
Approved Indication
FDA-approved for adult patients with folate receptor-alpha (FR-alpha) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.FDA批准用于治疗叶酸受体alpha (FR-alpha) 阳性、且对铂类药物耐药的晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者(既往接受过1-3种系统治疗方案)。
What This Means For Patients
ELAHERE is an antibody-drug conjugate targeting folate receptor alpha (FR-alpha). It is approved by the FDA for platinum-resistant ovarian cancers and is available under the Hainan special import policy.ELAHERE 是一种针对叶酸受体alpha (FR-alpha) 的抗体偶联药物(ADC)。其已获美国FDA批准用于铂类耐药性卵巢癌,并可在海南博鳌乐城先行区特许引进通道中申请临床使用。
Regulatory Approvals
- FDA — approved (2024) — source
Pivotal Clinical Evidence
- MIRASOL — Moore et al., N Engl J Med 2023 (NCT04209855) — DOI
Sources
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.