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6-K: Jemperli (Dostarlimab) Receives Us Fda Breakthrough Therapy Designation for Locally Advanced Dmmr/Msi-H Rectal Cancer

6-K: Jemperli (Dostarlimab) Receives Us Fda Breakthrough Therapy Designation for Locally Advanced Dmmr/Msi-H Rectal Cancer

6-K：Jemperli（Dostarlimab）獲得美國FDA局部晚期Dmmr/Msi-H直腸癌突破性療法認定
美股SEC公告 ·  2024/12/16 08:37

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GSK announced that Jemperli (dostarlimab) has received FDA Breakthrough Therapy Designation for treating locally advanced dMMR/MSI-H rectal cancer. The designation is based on remarkable clinical trial results showing 100% complete response rate in all 42 treated patients, with the first 24 patients maintaining sustained response over a median follow-up of 26.3 months.The breakthrough status aims to expedite development and review of drugs showing substantial improvement over existing therapies. This marks Jemperli's second regulatory designation for this indication, following its Fast Track designation in January 2023. The treatment demonstrated a favorable safety profile with no grade 3 or higher adverse events reported.Current standard treatment for dMMR/MSI-H rectal cancer involves chemotherapy, radiation, and surgery, which can lead to significant quality-of-life impacts including bowel dysfunction and infertility. GSK's ongoing phase II AZUR-1 trial seeks to confirm these promising results, potentially offering a paradigm-shifting treatment option for patients with this condition.
GSK announced that Jemperli (dostarlimab) has received FDA Breakthrough Therapy Designation for treating locally advanced dMMR/MSI-H rectal cancer. The designation is based on remarkable clinical trial results showing 100% complete response rate in all 42 treated patients, with the first 24 patients maintaining sustained response over a median follow-up of 26.3 months.The breakthrough status aims to expedite development and review of drugs showing substantial improvement over existing therapies. This marks Jemperli's second regulatory designation for this indication, following its Fast Track designation in January 2023. The treatment demonstrated a favorable safety profile with no grade 3 or higher adverse events reported.Current standard treatment for dMMR/MSI-H rectal cancer involves chemotherapy, radiation, and surgery, which can lead to significant quality-of-life impacts including bowel dysfunction and infertility. GSK's ongoing phase II AZUR-1 trial seeks to confirm these promising results, potentially offering a paradigm-shifting treatment option for patients with this condition.
GSk宣佈，Jemperli（dostarlimab）獲得FDA突破性療法的認證，用於治療局部晚期dMMR/MSI-H直腸癌。這一認證基於臨牀試驗的顯著結果，42名接受治療的患者中，100%實現完全響應，其中前24名患者在中位隨訪26.3個月的時間內保持持續反應。突破性狀態旨在加快對顯示出相對於現有療法有實質改善的藥物的開發和審核。這標誌着Jemperli在該適應症上的第二個監管認證，繼2023年1月獲得快速通道認證後。該治療顯示出良好的安全性，沒有報告3級或更高的不良事件。目前針對dMMR/MSI-H直腸癌的標準治療包括化療、放療和手術，這可能導致顯著的生活質量下降，包括腸道功能障礙和不孕不育。GSK正在進行的II期AZUR-1試驗旨在確認這些有希望的結果，可能爲該控制項的患者提供一種改變遊戲規則的治療選擇。
GSk宣佈，Jemperli（dostarlimab）獲得FDA突破性療法的認證，用於治療局部晚期dMMR/MSI-H直腸癌。這一認證基於臨牀試驗的顯著結果，42名接受治療的患者中，100%實現完全響應，其中前24名患者在中位隨訪26.3個月的時間內保持持續反應。突破性狀態旨在加快對顯示出相對於現有療法有實質改善的藥物的開發和審核。這標誌着Jemperli在該適應症上的第二個監管認證，繼2023年1月獲得快速通道認證後。該治療顯示出良好的安全性，沒有報告3級或更高的不良事件。目前針對dMMR/MSI-H直腸癌的標準治療包括化療、放療和手術，這可能導致顯著的生活質量下降，包括腸道功能障礙和不孕不育。GSK正在進行的II期AZUR-1試驗旨在確認這些有希望的結果，可能爲該控制項的患者提供一種改變遊戲規則的治療選擇。
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