基石藥業(02616.HK)合作伙伴向美國FDA提交pralsetinib治療晚期RET突變和RET融合陽性甲狀腺癌新藥上市申請
格隆匯 7 月 20日丨基石藥業-B(02616.HK)發佈公告,公司的合作伙伴 Blueprint Medicines Corporation(納斯達克股份代號:BPMC)於2020年7月上旬宣佈向美國食品和藥物監管局(“FDA”)提交了 pralsetinib 的新藥上市申請,用於治療晚期或轉移性 RET 突變甲狀腺髓樣癌(“MTC”)和 RET 融合陽性甲狀腺癌患者。pralsetinib 是一種在研口服、強效,高選擇性抑制 RET 融合和突變,包括預測性耐藥突變的精準靶向治療藥物,每日一次服用方便。
Blueprint Medicines 在美國 FDA 即時腫瘤學審評試點項目(“RTOR 專案”)下提交了這一新藥上市申請,RTOR 專案是美國 FDA 腫瘤卓越中心的一項新舉措。RTOR 專案旨在探索更高效的審查流程,以確保患者儘早獲得安全有效的治療,同時保持並提高美國 FDA 的審查品質。
Blueprint Medicines 於2020年5月宣佈,pralsetinib 治療 RET 融合陽性局部晚期或轉移性非小細胞肺癌(“NSCLC”)在美國和歐盟的上市申請已分別獲得美國 FDA 受理和歐洲藥品管理局驗證。
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