食品和药物管理局批准Darzalex Faspro 用于高危险发霉的骨髓瘤,改善无进展生存。 FDA approves Darzalex Faspro for high-risk smoldering myeloma, improving progression-free survival.

林业发展局批准了Darzalex Faspro(daratumumumab和hyaluronidase-fihj),根据AQUILA案的审判,作为针对高危发烧多处骨髓瘤的成年人的亚皮单疗法。 The FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a subcutaneous monotherapy for adults with high-risk smoldering multiple myeloma, based on the AQUILA trial. 治疗大大改善了无进展生存,中位PFS没有达到中位数,而监测组的中位数为41.5个月,疾病演变风险减少了51%。 The treatment significantly improved progression-free survival, with median PFS not reached compared to 41.5 months in the monitoring group, a 51% reduction in disease progression risk. 病人最初每周服用剂量,然后每两周连续24周服用一次剂量,然后每月服用一次剂量。 Patients received weekly dosing initially, then every two weeks through week 24, followed by monthly doses. 治疗延缓了第一线治疗的时间,显示在5年内总体存活率很高。 The therapy delayed time to frontline treatment and showed strong overall survival at five years. 药物耐受性良好,停药率低,在3到5分钟内进行. It is well-tolerated with a low discontinuation rate and is administered in 3 to 5 minutes. 此项批准标志着在早期干预高危发霉性骨髓瘤方面的一项关键进展。 The approval marks a key advancement in early intervention for high-risk smoldering myeloma.