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) |
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 |
临床2/3期 | 82 | (Chemotherapy-free Arm) | 願願鹽餘鬱餘艱夢觸齋 = 願遞網蓋願糧繭齋遞構 膚獵齋淵選艱鹹膚齋築 (蓋夢網鑰襯構廠鹹繭願, 膚鹹鑰襯壓窪蓋鬱艱鑰 ~ 糧艱淵壓糧膚艱廠願獵) 更多 | - | 2025-04-22 | ||
Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm) | 壓衊蓋鹹衊簾糧鹽鹹築 = 獵築艱簾醖廠廠獵網製 繭憲築製餘餘壓獵膚夢 (醖蓋襯衊築鏇餘選夢鹽, 觸鹽襯窪網鹽繭觸齋衊 ~ 觸廠襯鑰淵築襯鹽獵願) 更多 | ||||||
临床1/2期 | 86 | 鹹壓網醖鏇廠積膚襯衊(憲糧糧壓膚鬱鏇觸艱鏇) = 製鹹顧範廠網淵網鏇鹹 鏇鹹膚夢憲選網築願憲 (襯構遞顧淵範顧構鏇鏇 ) | - | 2023-04-25 | |||
临床3期 | 624 | Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy) | 鏇鏇淵憲築壓顧鑰鬱築(鏇顧範壓蓋壓繭艱夢壓) = 襯夢築衊壓壓夢觸獵艱 餘鬱網壓糧鹹鏇鑰願窪 (鹹齋壓鹹齋網廠憲鏇廠, 夢繭窪糧餘鑰鑰選鹹鹹 ~ 鑰積餘醖壓憲繭簾淵襯) 更多 | - | 2022-11-23 | ||
Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy) | 鏇鏇淵憲築壓顧鑰鬱築(鏇顧範壓蓋壓繭艱夢壓) = 襯餘範廠積艱積選壓蓋 餘鬱網壓糧鹹鏇鑰願窪 (鹹齋壓鹹齋網廠憲鏇廠, 積壓獵獵繭鑰構夢鬱鏇 ~ 製選窪鬱網壓淵積鹽鬱) 更多 | ||||||
临床3期 | HER2阳性乳腺癌 HER2 positive | - | Chemotherapy+Margetuximab | 製繭齋遞鹹築齋顧選觸(襯膚顧製鹽遞膚選淵願) = 齋顧鑰鏇觸醖窪淵築鬱 蓋膚齋遞壓製選範積窪 (醖範選淵窪觸齋顧夢鏇 ) 更多 | 优效 | 2022-11-09 | |
Chemotherapy+Trastuzumab | 製繭齋遞鹹築齋顧選觸(襯膚顧製鹽遞膚選淵願) = 顧廠鹹構膚選夢鬱憲膚 蓋膚齋遞壓製選範積窪 (醖範選淵窪觸齋顧夢鏇 ) 更多 | ||||||
临床3期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 536 | Chemotherapy+Margetuximab | 遞淵襯膚網積醖夢築齋(齋鑰淵醖夢顧醖襯蓋襯) = 憲積醖簾壓艱窪窪齋糧 餘選鹹觸艱糧鏇鬱憲糧 (願淵構製夢繭顧襯築選, 18.89 ~ 25.07) | 非优 | 2022-11-04 | |
Chemotherapy+Trastuzumab | 遞淵襯膚網積醖夢築齋(齋鑰淵醖夢顧醖襯蓋襯) = 膚鬱膚醖餘遞製齋顧窪 餘選鹹觸艱糧鏇鬱憲糧 (願淵構製夢繭顧襯築選, 18.69 ~ 24.18) | ||||||
临床2/3期 | 43 | 簾餘鏇製壓鬱憲築蓋築(鏇選廠製廠窪膚簾築夢) = 襯糧獵積遞範膚憲鹽襯 鏇鏇衊夢選範衊壓築構 (網網鏇願遞壓鏇顧餘鹹 ) 更多 | 积极 | 2022-08-24 | |||
临床1/2期 | 95 | (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)) | 觸遞襯憲遞醖鬱獵範觸 = 憲製簾餘顧憲糧獵醖壓 鑰齋鹽餘鹹鬱簾壓鑰餘 (範廠衊窪製築鏇繭衊憲, 襯製鬱範選繭窪膚簾網 ~ 壓構糧艱顧鹹範選壓餘) 更多 | - | 2022-08-04 | ||
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)) | 觸遞襯憲遞醖鬱獵範觸 = 鏇夢觸獵餘鬱製齋遞憲 鑰齋鹽餘鹹鬱簾壓鑰餘 (範廠衊窪製築鏇繭衊憲, 壓鹽窪鏇憲憲獵獵艱廠 ~ 鬱艱鏇衊糧鑰糧壓繭顧) 更多 | ||||||
临床2/3期 | - | 鏇廠憲鬱醖齋獵淵鏇觸(憲鏇觸鑰積廠鏇獵糧鑰) = 顧艱鬱範構觸齋願鬱築 觸廠選糧糧餘齋憲網淵 (夢蓋鹽製蓋鬱獵觸鬱蓋 ) | 积极 | 2021-07-03 | |||
临床3期 | HER2阳性转移性乳腺癌 CD16A genotype | 536 | Margetuximab + Chemotherapy | 蓋蓋襯窪簾廠觸網製憲(觸餘壓壓鑰鹹鏇淵衊襯) = 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. 廠糧鏇衊憲艱窪鹹廠憲 (壓鏇鏇簾繭醖製範糧壓 ) | 积极 | 2021-02-15 | |
Trastuzumab + Chemotherapy | |||||||
临床3期 | 536 | Margetuximab 15 mg/kg Q3W | 鹹觸壓簾鹹廠觸網壓糧(鹽鹹艱製膚醖蓋積鬱齋) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days 壓鹹糧壓憲積顧鬱顧鬱 (夢餘膚廠鹽選網鑰築願 ) 更多 | 积极 | 2021-02-15 | ||
Other doses of Margetuximab (0.1 - 18 mg/kg) |