欧盟批准teclistamab单药用于更早期多发性骨髓瘤
EU approves teclistamab monotherapy for earlier myeloma use
Johnson & Johnson 获得欧盟委员会批准，将 teclistamab 单药适应症扩展至已接受至少一种既往治疗的复发或难治性多发性骨髓瘤成人患者，进入二线治疗。该决定基于 III 期数据，显示相比标准治疗，teclistamab 将疾病进展或死亡风险降低 71%、死亡风险降低 40%。更新后的标签还引入简化给药方案，包括从第 7 个月起每月给药，以及符合条件患者可更早转换。
该批准把双特异性T细胞衔接器推进至二线，并附有III期PFS与OS数据及简化给药方案。
Second-line authorisation expands immunotherapy options
Johnson & Johnson has secured European Commission approval for an indication extension of teclistamab monotherapy for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
The decision broadens access to the bispecific T‑cell engager in the second-line setting and follows the recent approval of teclistamab plus daratumumab.
Many patients relapse after first-line treatment and options narrow once disease becomes refractory to established classes. The company said the new authorisation reinforces the potential of teclistamab across monotherapy and combination approaches at first relapse.
Cyrille Touzeau explained: “Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making effective treatment at first relapse increasingly important.
“The approval of teclistamab monotherapy gives physicians an additional immunotherapy option in the second-line setting, supported by significant improvements in both progression-free and overall survival.”
Ester in ’t Groen said: “Building on the recent approval of teclistamab plus daratumumab, this European Commission further reinforces the strength of bispecific-based immunotherapy approaches as early as second line.
“Together, the MajesTEC-3 and MajesTEC-9 studies support the potential of teclistamab-based therapies to advance the treatment paradigm and improve outcomes for patients earlier in their disease journey.”
Yusri Elsayed added: “Today’s approval marks another important step in our ambition to bring innovative immunotherapies earlier in the treatment journey for patients with multiple myeloma.”
“With positive phase 3 results from both MajesTEC-3 and MajesTEC-9, we continue to build evidence for teclistamab-based regimens across a broad second-line patient population.”
The EC decision is supported by phase 3 data showing teclistamab reduced risk of disease progression or death by 71% and risk of death by 40% compared with standard of care. The updated label introduces a simplified dosing schedule, including monthly dosing from month 7 and earlier transition for eligible patients.
来源：PharmaTimes · pharmatimes.com