GSK plc (LSE/NYSE: GSK) today announced the approval of Blenrep combinations by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with relapsed or refractory multiple myeloma. The approval is based on positive results from the DREAMM-7 and DREAMM-8 phase III trials evaluating Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in patients with multiple myeloma who have received at least one prior therapy. The approval follows an orphan drug designation for Blenrep in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma.

葛兰素史克公司 (GSK plc) (伦敦证券交易所/纽约证券交易所代码：GSK) 今日宣布，日本厚生劳动省 (MHLW) 批准Blenrep复方制剂用于治疗复发或难治性多发性骨髓瘤成人患者。此项批准基于 DREAMM-7 和 DREAMM-8 III 期临床试验的积极结果，分别评估了Blenrep与硼替佐米联合地塞米松 (BVd) 和与泊马度胺联合地塞米松 (BPd) 联合治疗，用于治疗至少接受过一种既往疗法的多发性骨髓瘤患者。此前，Blenrep已在日本获得孤儿药资格认定，该资格认定是基于其能够满足多发性骨髓瘤患者尚未满足的大量需求而授予的。

Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHLW approval of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.

关键的 DREAMM-7 和 DREAMM-8 III 期临床试验在治疗复发或难治性多发性骨髓瘤方面取得了卓越的疗效，这支持厚生劳动省 (MHLW) 批准Blenrep组合疗法。这些结果包括： Blenrep组合疗法与标准疗法相比，在两项试验中均获得了具有统计学意义和临床意义的无进展生存期 (PFS) 结果，以及DREAMM - 7中的总生存期 (OS)。2、3、4 Blenrep组合疗法的安全性和耐受性概况与已知的单个药物概况大致一致。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Today’s approval brings the benefits of Blenrep combinations to patients with relapsed or refractory multiple myeloma in Japan. Patients need additional treatment options at or after first relapse that can extend remission and survival versus standard of care. Blenrep combinations have the potential to redefine treatment outcomes based on superior efficacy shown in two phase III trials, with the added advantage of in-office administration in both academic and community treatment settings.”

葛兰素史克公司高级副总裁兼全球肿瘤研发主管 Hesham Abdullah 表示： “今天的批准将Blenrep联合疗法的益处带给了日本复发或难治性多发性骨髓瘤患者。患者在首次复发时或复发后需要额外的治疗方案，以延长缓解期和生存期，优于标准治疗。Blenrep联合疗法有望重新定义治疗结果，这得益于两项 III 期试验中显示的卓越疗效，并且能够在学术和社区治疗环境中进行诊室给药。”

Most patients with multiple myeloma experience relapse, and in Japan only about 43% remain alive five years after diagnosis.5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients at or after relapse with a differentiated mechanism of action. Blenrep combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation.

大多数多发性骨髓瘤患者都会经历复发，在日本， 确诊五年后存活率仅为43%。Blenrep是唯一获批用于治疗多发性骨髓瘤的抗BCMA（B细胞成熟抗原）抗体-药物偶联物(ADC)，可为复发时或复发后的患者提供差异化​​的作用机制。Blenrep联合疗法可用于各种类型的肿瘤治疗，无需复杂的给药前方案或住院治疗。

In the DREAMM-7 and DREAMM-8 clinical trials, Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators

在 DREAMM-7 和 DREAMM-8 临床试验中，Blenrep组合疗法持续惠及广泛患者，包括预后特征或预后不良的患者，例如高危细胞遗传学患者或对来那度胺耐药的患者。两项试验均显示，所有其他次要疗效终点均有临床意义的改善，包括与相应的对照药物相比，疗效更显著、更持久。

Eye-related side effects associated with Blenrep were successfully managed by extending time between infusions and through dose reductions, allowing patients to maintain benefit and resulting in low rates of discontinuation (≤9%) in both trials.2,3 Eye exam findings and changes in visual clarity (known as visual acuity) resolved in 83% of occurrences; with the trials ongoing, the remaining occurrences were in patients with follow-up ongoing or lost to follow-up. There have been no confirmed cases of permanent bilateral vision loss (i.e., no permanent bilateral eye exam findings of 20/200 or worse) based on current Blenrep clinical trial data and previous monotherapy post-marketing use.6 The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep combination arm of DREAMM-8.

通过延长输注间隔时间和减少剂量，Blenrep相关的眼部副作用得到了成功控制，使患者能够维持获益，并导致两项试验的停药率较低（≤9%）。2、3眼科检查结果和视觉清晰度变化（即视力）在 83% 的病例中得到缓解；随着试验的进行，其余病例发生在后续随访或失访的患者中。根据目前的Blenrep临床试验数据和先前的单药治疗上市后使用情况，尚未确诊永久性双侧视力丧失（即没有永久性双侧眼科检查结果为 20/200 或更差）的病例。6 Blenrep联合治疗组最常报告的非眼部不良事件（>30% 的参与者）是 DREAMM-7 中的血小板减少症（87%）和腹泻（32%），以及 DREAMM-8 的Blenrep联合治疗组中的中性粒细胞减少症（63%）、血小板减少症（55%）和 COVID-19（37%）。

This is the second major regulatory approval for Blenrep combinations for the treatment of relapsed or refractory multiple myeloma, following the first authorisation in the world last month by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

这是Blenrep组合疗法用于治疗复发或难治性多发性骨髓瘤的第二次重大监管批准，上个月英国药品和保健产品管理局 (MHRA) 首次批准该疗法。

Blenrep combinations are currently under review in all major markets globally, including in the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025,7 European Union,8 China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application),9 Canada, and Switzerland (with priority review for DREAMM-8).

Blenrep组合目前正在全球所有主要市场接受审查，包括我们处方药使用者付费法案 (PDUFA) 生效日期为 2025 年 7 月 23 日，7 欧洲联盟，8 中国（基于 DREAMM-7 的结果，该组合获得突破性疗法认定，且申请获得优先审查）、9加拿大和瑞士（DREAMM-8 获得优先审查）。