君實生物-B(01877.HK)特瑞普利單抗聯合阿昔替尼治療黏膜黑色素瘤獲美國藥監局頒發孤兒藥資格認定
格隆匯3月27日丨君實生物-B(01877.HK)公佈,公司產品特瑞普利單抗聯合阿昔替尼(美國輝瑞公司產品)治療黏膜黑色素瘤獲得美國食品藥品監督管理局(美國藥監局)頒發孤兒藥資格認定。
黏膜黑色素瘤是黑色素瘤的亞型之一,其對傳統化療不敏感,對單藥免疫治療的反應率也極其有限,臨牀前研究顯示免疫聯合VEGFR靶向治療可協同抑制腫瘤生長。2019年8月12日,特瑞普利單抗聯合阿昔替尼治療晚期黏膜型黑色素瘤的研究(NCT03086174)結果發表於《臨牀腫瘤學雜誌》(Journalof Clinical Oncology),該研究顯示特瑞普利單抗聯合阿昔替尼治療未接受過化療的晚期黏膜黑色素瘤患者可獲得48.3%的客觀緩解率(ORR)及86.2%的疾病控制率(DCR),中位無進展生存期(mPFS)達7.5個月。
本次獲得美國藥監局頒發的孤兒藥資格認定,有助於該聯合用藥在美國的後續研發、註冊及商業化等享受一定的政策支持,包括但不限於臨牀試驗費用的税收抵免;免除新藥申請費;享有7年的市場獨佔權且不受專利的影響。本次認定將在一定程度上降低該聯合用藥的研發投入,加快推進臨牀試驗以及上市註冊的進度。
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