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6-K: Gsk's B7-H3-Targeted Antibody-Drug Conjugate, Gsk'227, Receives Us Fda Breakthrough Therapy Designation in Late-Line Relapsed or Refractory Osteosarcoma

6-K: Gsk's B7-H3-Targeted Antibody-Drug Conjugate, Gsk'227, Receives Us Fda Breakthrough Therapy Designation in Late-Line Relapsed or Refractory Osteosarcoma

6-K：葛兰素史克的B7-H3靶向抗体-药物共轭物GSK'227在晚期复发或难治性骨肉瘤中获得美国FDA突破性疗法认定
美股SEC公告 ·  01/07 19:39

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GSK announced that its B7-H3-targeted antibody-drug conjugate (GSK'227) has received FDA Breakthrough Therapy Designation for treating adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior therapies. This marks the drug's third regulatory designation, following EMA's PRIME designation and FDA's Breakthrough status for small-cell lung cancer in 2024.The designation is supported by data from the ARTEMIS-002 phase II trial, which enrolled over 60 patients, including 42 with osteosarcoma. GSK recently initiated a global phase I trial as part of the development plan to support a registrational pathway for GSK'227, following its acquisition of exclusive worldwide rights from Hansoh Pharma (excluding Greater China).Osteosarcoma, the most common primary bone cancer affecting mainly children and young adults, has an annual incidence of 3.3 patients per million in the US. The condition currently lacks FDA-approved treatments for patients who have progressed on two prior lines of therapy, highlighting a significant unmet medical need in this rare cancer type.
GSK announced that its B7-H3-targeted antibody-drug conjugate (GSK'227) has received FDA Breakthrough Therapy Designation for treating adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior therapies. This marks the drug's third regulatory designation, following EMA's PRIME designation and FDA's Breakthrough status for small-cell lung cancer in 2024.The designation is supported by data from the ARTEMIS-002 phase II trial, which enrolled over 60 patients, including 42 with osteosarcoma. GSK recently initiated a global phase I trial as part of the development plan to support a registrational pathway for GSK'227, following its acquisition of exclusive worldwide rights from Hansoh Pharma (excluding Greater China).Osteosarcoma, the most common primary bone cancer affecting mainly children and young adults, has an annual incidence of 3.3 patients per million in the US. The condition currently lacks FDA-approved treatments for patients who have progressed on two prior lines of therapy, highlighting a significant unmet medical need in this rare cancer type.
GSk 宣布其 B7-H3 靶向抗体药物联合体 (GSK'227) 已获得 FDA 突破疗法指定，用于治疗已接受至少两种前期治疗的复发或难治性骨肉瘤成年患者。这标志着该药物获得的第三个监管指定，此前分别为 EMA 的 PRIME 指定和 2024 年 FDA 针对小细胞肺癌的突破状态。该指定的数据支持来自 ARTEMIS-002 II 期试验，该试验招募了超过 60 名患者，其中包括 42 名骨肉瘤患者。GSk 最近启动了一项全球 I 期试验，作为支持 GSK'227 注册路径的开发计划的一部分，此前它已从翰森制药获得了全球独占权（不包括大中华地区）。骨肉瘤是最常见的原发性骨癌，主要影响儿童和年轻成年人，在美国的年发病率为每百万 3.3 名患者。该控件目前缺乏 FDA 批准的治疗方案，适用于已接受两种前期治疗的患者，这突显出这一罕见癌症类型的重大未满足的医疗需求。
GSk 宣布其 B7-H3 靶向抗体药物联合体 (GSK'227) 已获得 FDA 突破疗法指定，用于治疗已接受至少两种前期治疗的复发或难治性骨肉瘤成年患者。这标志着该药物获得的第三个监管指定，此前分别为 EMA 的 PRIME 指定和 2024 年 FDA 针对小细胞肺癌的突破状态。该指定的数据支持来自 ARTEMIS-002 II 期试验，该试验招募了超过 60 名患者，其中包括 42 名骨肉瘤患者。GSk 最近启动了一项全球 I 期试验，作为支持 GSK'227 注册路径的开发计划的一部分，此前它已从翰森制药获得了全球独占权（不包括大中华地区）。骨肉瘤是最常见的原发性骨癌，主要影响儿童和年轻成年人，在美国的年发病率为每百万 3.3 名患者。该控件目前缺乏 FDA 批准的治疗方案，适用于已接受两种前期治疗的患者，这突显出这一罕见癌症类型的重大未满足的医疗需求。
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