FDA批准Darzalex Faspro用于高危冒烟型多发性骨髓瘤，依据III期AQUILA试验
美国食品药品管理局（FDA）11月6日批准达雷妥尤单抗与透明质酸酶复方制剂（daratumumab and hyaluronidase-fihj，商品名Darzalex Faspro）用于治疗高危冒烟型多发性骨髓瘤成人患者。
此次批准依据III期AQUILA试验（NCT03301220）的数据。2025年5月，FDA肿瘤药物咨询委员会曾以6票对2票表决支持皮下注射达雷妥尤单抗作为高危冒烟型多发性骨髓瘤单药治疗的风险获益比。
冒烟型多发性骨髓瘤是多发性骨髓瘤的无症状前驱阶段，其中高危患者进展为活动性多发性骨髓瘤的风险较高。Darzalex Faspro此前已获批用于多发性骨髓瘤的其他多个治疗场景，本次为其适应证的又一次扩展。
图中是美国食品药品管理局（FDA）总部1号楼外观。
FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma, Based on Phase 3 AQUILA Trial
On November 6, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).
The regulatory decision was supported by data from the Phase 3 AQUILA trial (NCT03301220). In May 2025, the FDA's Oncologic Drugs Advisory Committee had voted 6 to 2 in favor of the risk-benefit profile of subcutaneous daratumumab as monotherapy for high-risk smoldering multiple myeloma, based on AQUILA.
Smoldering multiple myeloma is an asymptomatic precursor stage of multiple myeloma, and patients classified as high-risk face a greater likelihood of progressing to active disease. Darzalex Faspro was previously approved in several other multiple myeloma treatment settings, and this decision extends its indications further.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：图中是美国食品药品管理局（FDA）总部1号楼外观。Wikimedia Commons / U.S. Food and Drug Administration, Public domain
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