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美股SEC公告 ·  01/07 01:39

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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宣佈其B7-H3靶向抗體-藥物偶聯物(GSK'227)已獲得FDA突破性治療認證，用於治療已接受至少兩種前期療法的復發或難治性骨肉瘤成人患者。這標誌着該藥物的第三個監管認證，在此之前還獲得了EMA的PRIME認證和FDA對小細胞肺癌的突破性地位，後者於2024年獲得。該認證得到了ARTEMIS-002 II期臨牀試驗的數據支持，該試驗共招募了超過60名患者，其中包括42名骨肉瘤患者。GSk近期啓動了一項全球I期臨牀試驗，作爲開發計劃的一部分，以支持GSK'227的註冊路徑，此前其從翰森製藥（不包括大中華地區）獲得了獨家全球權利。骨肉瘤是最常見的原發性骨癌，主要影響兒童和年輕成年人，在美國的年發病率爲每百萬中3.3名患者。該疾病目前缺乏FDA批准的治療方法，適用於已在兩條前期治療上進展的患者，這突出強調了這一罕見癌症類型中存在重大未滿足的醫療需求。
GSk宣佈其B7-H3靶向抗體-藥物偶聯物(GSK'227)已獲得FDA突破性治療認證，用於治療已接受至少兩種前期療法的復發或難治性骨肉瘤成人患者。這標誌着該藥物的第三個監管認證，在此之前還獲得了EMA的PRIME認證和FDA對小細胞肺癌的突破性地位，後者於2024年獲得。該認證得到了ARTEMIS-002 II期臨牀試驗的數據支持，該試驗共招募了超過60名患者，其中包括42名骨肉瘤患者。GSk近期啓動了一項全球I期臨牀試驗，作爲開發計劃的一部分，以支持GSK'227的註冊路徑，此前其從翰森製藥（不包括大中華地區）獲得了獨家全球權利。骨肉瘤是最常見的原發性骨癌，主要影響兒童和年輕成年人，在美國的年發病率爲每百萬中3.3名患者。該疾病目前缺乏FDA批准的治療方法，適用於已在兩條前期治療上進展的患者，這突出強調了這一罕見癌症類型中存在重大未滿足的醫療需求。
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