FYARRO sirolimus protein-bound particles
Drug Class
mTOR kinase inhibitormTOR 激酶抑制剂（白蛋白结合纳米型）
Mechanism
Inhibits downstream signals of mTORC1 activation, inducing cell-cycle arrest and apoptosis in tumor cells highly sensitive to mTOR alterations.靶向阻断 mTORC1 激活的下游信号通路，诱导肿瘤细胞周期停滞和凋亡，提高靶向肿瘤组织内的局部药物浓度。
Approved Indication
FDA-approved for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).FDA批准用于治疗局部晚期不可切除或转移性恶性血管周围上皮样细胞瘤 (PEComa) 成人患者。
What This Means For Patients
FYARRO is an albumin-bound formulation of sirolimus targeting advanced malignant PEComa. Approved by the FDA, it is clinically accessible under Hainan pilot-zone regulations.FYARRO 是一种将西罗莫司结合在人血白蛋白纳米颗粒上的新型靶向 mTOR 抑制剂。其已获得 FDA 批准用于恶性 PEComa 肉瘤，可在海南博鳌乐城先行区特许使用。
Regulatory Approvals
- FDA — approved (2021) — label
Pivotal Clinical Evidence
- AMPECT — Wagner et al., J Clin Oncol 2021 (NCT02494570) — DOI
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.