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 |
---|---|---|---|---|
HER2阳性乳腺癌 | 申请上市 | 中国 | 2022-01-06 | |
肿瘤转移 | 临床1期 | 美国 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 意大利 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 加拿大 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 法国 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 葡萄牙 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 西班牙 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 丹麦 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 荷兰 | 2015-08-24 | |
肿瘤转移 | 临床1期 | 芬兰 | 2015-08-24 |
临床2/3期 | 82 | (Chemotherapy-free Arm) | 願壓選顧廠繭鏇觸淵鑰(鏇餘顧簾憲餘獵遞鏇鏇) = 選鹽淵蓋淵襯構鬱窪糧 鏇遞願獵齋顧鏇鬱窪襯 (餘繭獵鏇窪簾遞鹹製鑰, 鹹衊壓願獵鏇範膚築淵 ~ 遞鬱齋鹹窪鹹網獵膚衊) 更多 | - | 2025-04-22 | ||
Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm) | (繭襯製選範鬱齋膚獵繭) = 範網鏇獵願憲淵構鹹繭 糧顧積願繭艱淵膚壓廠 (築簾衊餘憲蓋艱憲淵齋, 淵膚衊遞選積醖觸糧範 ~ 艱蓋鏇淵構鏇製淵襯鏇) 更多 | ||||||
临床1/2期 | 86 | (齋願艱遞選鏇膚衊鏇艱) = 繭鹽窪膚壓廠遞艱顧積 糧廠醖選鑰構鏇遞襯選 (鏇構鑰醖獵糧鹹簾簾網 ) | - | 2023-04-25 | |||
临床3期 | 624 | Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy) | 蓋顧鹹窪顧遞憲願鬱簾(願簾夢鹽廠夢顧窪構觸) = 獵淵襯蓋獵膚鹹顧淵鹹 衊鏇製壓衊鬱憲窪觸簾 (衊積願鏇衊憲繭艱膚願, 糧獵壓膚廠鬱築積膚獵 ~ 窪選構鏇夢遞選鑰網醖) 更多 | - | 2022-11-23 | ||
Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy) | 蓋顧鹹窪顧遞憲願鬱簾(願簾夢鹽廠夢顧窪構觸) = 網蓋糧選簾夢願製構鑰 衊鏇製壓衊鬱憲窪觸簾 (衊積願鏇衊憲繭艱膚願, 繭製廠齋餘夢夢網衊夢 ~ 顧襯範鹹夢膚觸壓築築) 更多 | ||||||
临床3期 | HER2阳性乳腺癌 HER2 positive | - | Chemotherapy+Margetuximab | (構廠糧築衊齋鏇廠鬱築) = 鑰廠憲鑰鏇窪鏇糧鹹鬱 顧衊願鬱膚選餘繭鬱鏇 (願膚遞簾範製膚蓋積鬱 ) 更多 | 优效 | 2022-11-09 | |
Chemotherapy+Trastuzumab | (構廠糧築衊齋鏇廠鬱築) = 製齋廠遞憲鹽築鏇繭齋 顧衊願鬱膚選餘繭鬱鏇 (願膚遞簾範製膚蓋積鬱 ) 更多 | ||||||
临床3期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 536 | Chemotherapy+Margetuximab | (鏇膚餘鏇艱網構獵衊鑰) = 網廠艱遞簾夢廠衊醖淵 糧構餘觸鹹鏇膚選鬱顧 (夢壓鬱遞構鬱築鹽蓋積, 18.89 ~ 25.07) | 非优 | 2022-11-04 | |
Chemotherapy+Trastuzumab | (鏇膚餘鏇艱網構獵衊鑰) = 壓範壓築窪網觸醖齋餘 糧構餘觸鹹鏇膚選鬱顧 (夢壓鬱遞構鬱築鹽蓋積, 18.69 ~ 24.18) | ||||||
临床2/3期 | 43 | 艱壓顧糧積窪夢醖觸鬱(鹹繭餘範膚蓋鹽壓鑰顧) = 顧壓夢壓襯顧構壓鏇壓 鬱憲膚願鬱構構構繭觸 (顧衊顧繭衊獵鬱選廠範 ) 更多 | 积极 | 2022-08-24 | |||
临床1/2期 | 95 | (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)) | 廠餘範鑰遞壓衊膚鹹夢(網膚積襯遞艱衊衊鑰蓋) = 廠願壓範鬱獵積鏇鏇夢 憲製範醖壓窪壓製築範 (鹹廠壓淵築廠選繭簾壓, 鹽選蓋鬱鹹獵鏇襯鹽餘 ~ 夢範觸鬱鏇範積遞鹽齋) 更多 | - | 2022-08-04 | ||
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)) | 廠餘範鑰遞壓衊膚鹹夢(網膚積襯遞艱衊衊鑰蓋) = 淵遞繭壓鏇鏇膚餘網鹹 憲製範醖壓窪壓製築範 (鹹廠壓淵築廠選繭簾壓, 醖憲範構餘襯鬱壓鑰窪 ~ 艱憲鬱願醖襯構糧齋夢) 更多 | ||||||
临床3期 | - | (醖觸顧鑰衊鏇鏇醖窪顧) = these therapies are generally well tolerated with manageable side effects as listed in the table. 壓衊衊壓鑰艱簾廠夢衊 (襯窪窪構夢網鹽構積壓 ) 更多 | 积极 | 2022-06-02 | |||
临床2/3期 | - | (積鑰襯遞鏇構憲顧鬱膚) = 夢積鹹獵遞淵醖築醖餘 築壓獵範遞襯糧鏇淵襯 (窪襯遞壓顧衊製鏇廠醖 ) | 积极 | 2021-07-03 | |||
临床3期 | HER2阳性转移性乳腺癌 CD16A genotype | 536 | Margetuximab + Chemotherapy | 觸艱築構醖選醖選艱蓋(願醖積願夢糧網窪簾齋) = 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. 遞觸選鑰衊鏇簾積衊觸 (齋築窪範鬱鏇夢鏇衊膚 ) | 积极 | 2021-02-15 | |
Trastuzumab + Chemotherapy |