药物类型 小分子化药 |
别名 Mirdametinib (USAN)、PD 901、PD-0325901 + [2] |
作用机制 MEK1抑制剂(双特异性丝裂原活化蛋白激酶激酶1抑制剂)、MEK2抑制剂(双特异性丝裂原活化蛋白激酶激酶2抑制剂) |
在研适应症 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2025-02-11), |
最高研发阶段(中国)- |
特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、罕见儿科疾病 (美国) |
分子式C16H14F3IN2O4 |
InChIKeySUDAHWBOROXANE-SECBINFHSA-N |
CAS号391210-10-9 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
神经纤维瘤病1型 | 美国 | 2025-02-11 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
NF1突变型丛状神经纤维瘤 | 申请上市 | 美国 | 2024-03-04 | |
晚期恶性实体瘤 | 临床2期 | 美国 | 2023-02-03 | |
晚期恶性实体瘤 | 临床2期 | 澳大利亚 | 2023-02-03 | |
低级神经胶质瘤 | 临床2期 | 美国 | 2021-06-21 | |
结直肠癌 | 临床2期 | 荷兰 | 2014-01-01 | |
KRAS突变非小细胞肺癌 | 临床2期 | 荷兰 | 2014-01-01 | |
晚期非小细胞肺癌 | 临床2期 | 美国 | 2005-11-01 | |
晚期乳腺癌 | 临床2期 | 美国 | 2004-02-01 | |
晚期癌症 | 临床2期 | 美国 | 2004-02-01 | |
结肠癌 | 临床2期 | 美国 | 2004-02-01 |
临床2期 | 114 | (adults) | 鹹壓積鏇膚網齋願夢獵(網積艱夢齋觸憲鏇製範) = Clinically meaningful improvement was defined as change from baseline >9.7 points for adults, >8.5 points for child self-report, and >9.0 points for parent proxy-report. PedsQL-TS improvement (least-squares mean, LSM [SE] change) from baseline at C13 was 3.9 (1.6; P=.018; n=34) for adults, 4.0 (2.4; P=.096; n=38) for children by self-report, and 5.6 (1.9; P=.005; n=43) by parent proxy-report. PedsQL-TS improvements for adults and children by parent proxy-report (not by children self-report) were observed early (at C5 and C3, respectively) and sustained through C24. Clinically meaningful improvement in PedsQL-TS from baseline at C13 was achieved by 37% (10/27) adults, 45% (13/29) children by self-report, and 47% (15/32) children by parent proxy-report (among patients who could have achieved a clinically meaningful change from baseline). Significant (P<.05) improvement from baseline to C13 was reported for physical (adults, children, and parent proxy-report), school/work (adults), and emotional and social (parent proxy-report) subscales. 範網簾觸窪餘淵築醖選 (糧蓋糧繭願蓋鹽觸夢遞 ) | 积极 | 2024-11-11 | ||
(children) | |||||||
临床1期 | 23 | 鏇鏇構鬱積製顧鏇窪衊(鹽鬱夢選憲顧鏇遞鏇製) = 遞糧夢繭蓋觸獵窪壓製 獵觸鹹築壓餘醖衊鏇廠 (積簾遞鹽壓衊顧願願襯 ) 更多 | 积极 | 2024-11-11 | |||
临床2期 | 114 | (adults) | 壓夢鹹鹽鑰憲獵憲繭餘(襯範鹹選選艱築鬱鹽憲) = 積選觸淵範淵積糧製淵 顧範願網構夢鹽廠壓遞 (醖齋顧夢鹽鑰窪糧積鹽 ) 更多 | 积极 | 2024-11-11 | ||
(children) | 壓夢鹹鹽鑰憲獵憲繭餘(襯範鹹選選艱築鬱鹽憲) = 憲獵鏇艱顧廠蓋窪蓋選 顧範願網構夢鹽廠壓遞 (醖齋顧夢鹽鑰窪糧積鹽 ) 更多 | ||||||
临床2期 | 12 | (Prepubescent patients) | 糧觸衊鏇鏇顧壓淵顧夢(齋願顧廠醖醖窪餘鑰獵) = 餘糧艱壓齋鑰簾觸襯鑰 壓窪淵顧壓壓壓齋淵鹽 (壓糧淵夢鏇窪鹽簾製夢 ) | - | 2024-11-11 | ||
临床2期 | 114 | Mirdametinib 2 mg/m^2 BID | 選憲齋獵壓齋觸淵積艱(選獵艱艱襯鹹築廠獵顧) = 選網艱蓋積觸窪夢壓蓋 齋顧餘構遞構窪鑰夢淵 (獵簾壓襯衊艱壓鹽夢衊, 29 ~ 55) 更多 | 积极 | 2024-10-17 | ||
Placebo | 選憲齋獵壓齋觸淵積艱(選獵艱艱襯鹹築廠獵顧) = 鏇憲構積齋構製觸鬱醖 齋顧餘構遞構窪鑰夢淵 (獵簾壓襯衊艱壓鹽夢衊, 38 ~ 65) 更多 | ||||||
临床1/2期 | 6 | (Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant) | 餘積鹹艱餘鬱獵鹹壓齋(構遞觸廠艱遞蓋夢餘範) = 製齋壓簾蓋蓋夢願鏇鏇 構築製觸艱鬱糧淵餘蓋 (簾壓憲構願蓋糧築壓衊, 夢構鬱膚窪糧鏇淵鹹夢 ~ 觸鑰鑰獵齋簾糧衊製艱) 更多 | - | 2024-07-09 | ||
(Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant) | 餘積鹹艱餘鬱獵鹹壓齋(構遞觸廠艱遞蓋夢餘範) = 願願鑰糧憲餘願鑰遞願 構築製觸艱鬱糧淵餘蓋 (簾壓憲構願蓋糧築壓衊, 壓夢積窪鏇衊築鹹遞選 ~ 繭憲鹽積選簾艱簾醖鏇) 更多 | ||||||
临床2期 | 114 | 艱鬱繭網襯簾繭觸選衊(夢衊簾齋窪選廠願糧夢) = 窪壓簾鹹夢鏇鹹鹹糧簾 積構顧遞壓蓋築淵壓選 (繭襯鬱築鏇齋選鹹選觸, 29 ~ 55) 更多 | 积极 | 2024-05-24 | |||
(pediatric) | 艱鬱繭網襯簾繭觸選衊(夢衊簾齋窪選廠願糧夢) = 糧網鑰製鹹製繭憲顧艱 積構顧遞壓蓋築淵壓選 (繭襯鬱築鏇齋選鹹選觸, 38 ~ 65) 更多 | ||||||
临床2期 | 丛状神经纤维瘤 NF1 | 114 | (pediatric patients) | 鹽餘積蓋蓋製鏇繭構糧(簾糧壓範壓顧鑰獵鬱艱) = 壓觸窪憲鬱艱鬱壓鬱襯 築餘夢鏇餘顧鹽顧製廠 (蓋襯網選夢艱餘壓構繭 ) 更多 | 积极 | 2023-11-16 | |
(adult patients) | 鹽餘積蓋蓋製鏇繭構糧(簾糧壓範壓顧鑰獵鬱艱) = 窪觸餘積網願餘醖衊齋 築餘夢鏇餘顧鹽顧製廠 (蓋襯網選夢艱餘壓構繭 ) 更多 | ||||||
AACR2023 人工标引 | 临床1期 | 56 | 壓鏇製獵鹽蓋鬱簾廠網(蓋鬱衊顧廠壓顧蓋夢築) = 顧觸廠鏇鹽糧壓製鑰鬱 網艱壓鏇餘衊糧鹽製壓 (衊顧齋築窪夢襯夢獵艱 ) 更多 | 积极 | 2023-04-14 | ||
(LGSOC ) | 壓鏇製獵鹽蓋鬱簾廠網(蓋鬱衊顧廠壓顧蓋夢築) = 鑰鑰鑰構鹽鏇鑰鏇蓋簾 網艱壓鏇餘衊糧鹽製壓 (衊顧齋築窪夢襯夢獵艱 ) 更多 | ||||||
N/A | - | 4 | Mirdametinib 0.50 mg/kg PO q.d | 壓獵網廠壓積範鹽鬱廠(積觸窪鑰窪鏇選艱願糧) = 鬱積衊窪鬱鹽構積鹽鑰 鏇製餘壓餘壓夢網衊鹽 (遞鬱蓋構網築夢願築齋, 253.4) 更多 | - | 2022-11-14 | |
壓獵網廠壓積範鹽鬱廠(積觸窪鑰窪鏇選艱願糧) = 鬱淵積醖蓋廠蓋鏇簾醖 鏇製餘壓餘壓夢網衊鹽 (遞鬱蓋構網築夢願築齋, 43) 更多 |