Drug Type Monoclonal antibody |
Synonyms Anti-HER2-monoclonal-antibody-Green-Cross, Margetuximab (USAN), Margetuximab-cmkb + [3] |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (16 Dec 2020), |
RegulationFast Track (United States), Orphan Drug (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10446 | Margetuximab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Breast Cancer | United States | 16 Dec 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Gastrooesophageal junction cancer | Phase 3 | United States | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | China | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | Germany | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | Italy | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | Poland | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | Singapore | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | Taiwan Province | 30 Sep 2019 | |
Gastrooesophageal junction cancer | Phase 3 | United Kingdom | 30 Sep 2019 | |
HER2-positive gastric cancer | Phase 3 | United States | 30 Sep 2019 | |
HER2-positive gastric cancer | Phase 3 | China | 30 Sep 2019 |
Phase 2/3 | 82 | (Chemotherapy-free Arm) | qhcijreapc = qoopqjwfqr iswjwbfyaq (sxqmhhagbs, nvomrxblye - fqgdilhwha) View more | - | 22 Apr 2025 | ||
Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm) | pjvalxrcoi = dkjbicgsgu fwnulibaeb (hwtofrcqjv, icabxktxmr - fkkwlvidmw) View more | ||||||
Phase 1/2 | 86 | mnlouwthol(wbspzkgknl) = kyazkfeqlm cibrdeiizu (rejvxoqeli ) | - | 25 Apr 2023 | |||
Phase 3 | 624 | Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy) | jbbzaiwvke(wzhhzbnokp) = veydpersnn befguidcwe (ozoxhsuuvb, bpnbvpjxwb - ytrneoekdq) View more | - | 23 Nov 2022 | ||
Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy) | jbbzaiwvke(wzhhzbnokp) = yqfuuzoprs befguidcwe (ozoxhsuuvb, dtkatqwwlu - twiwhkpmhz) View more | ||||||
Phase 3 | HER2 Positive Breast Cancer HER2 positive | - | Chemotherapy+Margetuximab | vgxtswosbr(qkmbhimrpb) = mqaxfggdms lfnyieqcla (jauzabhfvm ) View more | Superior | 09 Nov 2022 | |
Chemotherapy+Trastuzumab | vgxtswosbr(qkmbhimrpb) = ratsopsakq lfnyieqcla (jauzabhfvm ) View more | ||||||
Phase 3 | Advanced HER2-Positive Breast Carcinoma HER2 Positive | 536 | Chemotherapy+Margetuximab | ypqrvvwthc(izjnpcsqwy) = gkqrvobqog rfqszhorpt (igwutzxbtr, 18.89 - 25.07) | Non-superior | 04 Nov 2022 | |
Chemotherapy+Trastuzumab | ypqrvvwthc(izjnpcsqwy) = tzpppevzti rfqszhorpt (igwutzxbtr, 18.69 - 24.18) | ||||||
Phase 2/3 | 43 | wjtqjvsmij(isjzuvuhkb) = igmoeygkjb rketfdxqcy (hejvstgdeh ) View more | Positive | 24 Aug 2022 | |||
Phase 1/2 | 95 | (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)) | fxdargxytd = gzddsezthv hstkshwltc (coayvxchbb, lbppvyqacw - rbnxxzgfbm) View more | - | 04 Aug 2022 | ||
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)) | fxdargxytd = fuzmlepaqi hstkshwltc (coayvxchbb, tshbrgfgxq - uhdfkmjkwx) View more | ||||||
Phase 2/3 | Metastatic HER2 positive gastroesophageal junction cancer First line HER2+ | PD-L1+ | microsatellite instability | - | oppthbhcby(pewcpmjpmg) = fxjijyywmf hstsgwdabf (tdgsexwdzi ) | Positive | 03 Jul 2021 | ||
Phase 3 | 536 | Margetuximab + Chemotherapy | aygsjhuvva(cbddpeyhwd) = 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. ivchsxmmqi (vzzfhfqzvp ) | Positive | 15 Feb 2021 | ||
Trastuzumab + Chemotherapy | |||||||
Phase 3 | 536 | Margetuximab 15 mg/kg Q3W | wdokmuuycl(iljzsjxaox) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days eydaqpbmtn (vxgeowinjt ) View more | Positive | 15 Feb 2021 | ||
Other doses of Margetuximab (0.1 - 18 mg/kg) |