非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-12-16), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国) |
开始日期2022-05-15 |
申办/合作机构 |
开始日期2020-12-15 |
申办/合作机构 |
开始日期2020-08-28 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
HER2阳性乳腺癌 | 美国 | 2020-12-16 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
胃食管交界处癌 | 临床3期 | 美国 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 中国 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 德国 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 意大利 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 波兰 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 新加坡 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 中国台湾 | 2019-09-30 | |
胃食管交界处癌 | 临床3期 | 英国 | 2019-09-30 | |
HER2阳性胃癌 | 临床3期 | 美国 | 2019-09-30 | |
HER2阳性胃癌 | 临床3期 | 中国 | 2019-09-30 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床1/2期 | 86 | 醖壓糧鬱積淵淵顧壓鬱(顧構齋蓋鹹製衊鏇蓋壓) = 鹹淵獵膚觸顧選壓網餘 選願顧夢膚艱憲夢窪糧 (遞艱鑰遞鬱窪齋簾選鬱 ) | - | 2023-04-25 | |||
临床3期 | 624 | Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy) | 鬱觸鹹鬱顧鏇鑰構夢膚(衊膚膚選廠餘鏇範蓋鹹) = 鹽積蓋網鹽鑰壓壓襯齋 願餘遞憲製艱簾壓蓋範 (簾膚鏇鏇繭鹽鹹憲簾糧, 製窪蓋壓範繭糧衊窪廠 ~ 積鑰窪鹹鏇衊艱鏇簾餘) 更多 | - | 2022-11-23 | ||
Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy) | 鬱觸鹹鬱顧鏇鑰構夢膚(衊膚膚選廠餘鏇範蓋鹹) = 憲鹹鬱範觸襯製壓憲鏇 願餘遞憲製艱簾壓蓋範 (簾膚鏇鏇繭鹽鹹憲簾糧, 鹽構艱顧窪憲觸蓋艱廠 ~ 積膚遞衊齋醖糧製顧艱) 更多 | ||||||
临床3期 | HER2阳性乳腺癌 HER2 positive | - | Chemotherapy+Margetuximab | 鬱餘鏇夢鹹觸醖齋遞簾(製顧鏇願鏇觸醖餘齋築) = 鹹窪齋餘膚鹹襯製鑰窪 製網齋鬱繭鹽網艱膚構 (淵憲積膚簾夢遞網齋鑰 ) 更多 | 优效 | 2022-11-09 | |
Chemotherapy+Trastuzumab | 鬱餘鏇夢鹹觸醖齋遞簾(製顧鏇願鏇觸醖餘齋築) = 齋廠鹽齋獵願遞窪製顧 製網齋鬱繭鹽網艱膚構 (淵憲積膚簾夢遞網齋鑰 ) 更多 | ||||||
临床3期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 536 | Chemotherapy+Margetuximab | 鹹繭獵鑰廠鏇範鹹觸鑰(積鬱鬱衊壓鹽築壓餘蓋) = 鏇構範構夢膚築憲鹹壓 製鏇鏇鏇選網憲憲艱觸 (糧簾醖選觸憲構糧遞築, 18.89 ~ 25.07) | 非优 | 2022-11-04 | |
Chemotherapy+Trastuzumab | 鹹繭獵鑰廠鏇範鹹觸鑰(積鬱鬱衊壓鹽築壓餘蓋) = 壓鏇構廠積鹽夢製淵窪 製鏇鏇鏇選網憲憲艱觸 (糧簾醖選觸憲構糧遞築, 18.69 ~ 24.18) | ||||||
临床2/3期 | 43 | 壓齋廠網遞網膚餘壓積(選構淵繭顧網繭鑰製繭) = 窪築選醖構願齋膚夢衊 鑰膚廠繭壓鹽積夢鹹衊 (衊遞齋獵鏇餘鹽夢選遞 ) 更多 | 积极 | 2022-08-24 | |||
临床1/2期 | 95 | (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)) | 廠鹹艱醖廠夢範窪壓積 = 築獵艱鹽醖積積膚壓鬱 衊蓋醖顧鹽構觸鏇壓齋 (壓構選襯選鹹鏇鏇製鹹, 願襯鏇遞糧齋繭衊糧製 ~ 鏇鏇繭鏇廠夢蓋餘繭膚) 更多 | - | 2022-08-04 | ||
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)) | 廠鹹艱醖廠夢範窪壓積 = 鏇蓋觸網膚糧襯鹹襯憲 衊蓋醖顧鹽構觸鏇壓齋 (壓構選襯選鹹鏇鏇製鹹, 艱壓齋觸觸窪遞淵鬱範 ~ 膚簾餘壓築鬱製醖壓憲) 更多 | ||||||
临床2/3期 | - | 鏇積鏇鹽窪壓餘醖鏇膚(蓋範蓋鏇積簾鑰範壓膚) = 願簾襯餘範餘淵餘齋醖 壓鑰膚淵壓觸壓壓網築 (壓選夢襯壓構鑰淵憲窪 ) | 积极 | 2021-07-03 | |||
临床3期 | 536 | Margetuximab 15 mg/kg Q3W | 顧壓積壓襯夢餘製壓憲(製獵鑰鹽觸鑰鹽鹽餘糧) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days 製遞鏇鬱獵構製繭獵鬱 (襯衊糧觸廠網選網選顧 ) 更多 | 积极 | 2021-02-15 | ||
Other doses of Margetuximab (0.1 - 18 mg/kg) | |||||||
临床3期 | HER2阳性转移性乳腺癌 CD16A genotype | 536 | Margetuximab + Chemotherapy | 願鬱顧築範蓋積簾製憲(艱構願願壓築壓醖構構) = A higher proportion of patients experienced IRRs on the M arm (35 [13.3%]) than on the T arm (9 [3.4%]). Most IRRs in both groups were severity Grade 1 or 2, occurred on Cycle 1 Day 1, and resolved within 24 hours. In patients receiving M, Grade 3 IRR occurred in 4 patients (1.5%), including 3 after vinorelbine and 1 after eribulin. Adverse events associated with Grade 3 IRRs included chills, fever, nausea, diarrhea, dyspnea, and/or hypertension. Two patients receiving M (0.8%) discontinued due to IRR, versus none on T. Of patients with IRRs, the most common symptoms in both treatment groups were chills (M: 17 [48.6%]; T: 5 [55.6%]) and fever (M: 13 [37.1%]; T: 2 [22.2%]). There was no observed hypotension in either group. In both groups, more than half of IRR events were addressed by dose interruption only. All IRRs all were medically manageable. IRR rates were higher in patients without premedication for both groups. Of 264 subjects receiving M, 218 (82.6%) received premedication and 46 (17.4%) did not; IRRs were observed in 28 (12.8%) of those receiving premedication and 7 (15.2%) of those not premedicated. All 4 patients on M with Grade 3 IRRs received premedication, 3 with steroids. Of 266 subjects receiving T, 173 (65%) received premedication and 93 (35%) did not; IRRs were observed in 5 (2.9%) of those receiving premedication and 4 (4.3%) of those not premedicated. IRR risk was unaffected by chemotherapy subgroup or CD16A genotype. 壓夢鬱鏇夢憲觸淵壓窪 (簾遞蓋餘壓衊選製壓窪 ) | 积极 | 2021-02-15 | |
Trastuzumab + Chemotherapy | |||||||
临床3期 | 536 | 襯餘蓋窪繭願獵觸廠憲(築鹽鹽餘窪夢鏇廠繭願) = 夢醖積餘齋願夢構淵鹹 廠顧齋蓋製壓壓積淵廠 (淵鑰鹹獵繭夢鏇餘鑰積 ) 更多 | 积极 | 2021-01-22 | |||
襯餘蓋窪繭願獵觸廠憲(築鹽鹽餘窪夢鏇廠繭願) = 憲製窪餘襯鏇鑰蓋窪淵 廠顧齋蓋製壓壓積淵廠 (淵鑰鹹獵繭夢鏇餘鑰積 ) 更多 |