Drug Type Monoclonal antibody |
Synonyms Anti-Gd2 igg3 monoclonal antibody 3F8 humanized, Anti-Gd2 monoclonal antibody 3F8 humanized, Humanised 3F8 + [15] |
Target |
Mechanism GD2 inhibitors(Disialoganglioside GD2 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (25 Nov 2020), |
RegulationBreakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN) |
Start Date01 Mar 2024 |
Sponsor / Collaborator- |
Start Date31 Oct 2023 |
Sponsor / Collaborator |
Start Date19 Jun 2023 |
Sponsor / Collaborator |
Indication | Country/Location | Organization | Date |
---|---|---|---|
High Risk Neuroblastoma | US | 25 Nov 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Neuroblastoma | Phase 2 | HK | 02 Dec 2021 | |
Neuroblastoma | Phase 2 | RU | 02 Dec 2021 | |
Neuroblastoma | Phase 2 | SG | 02 Dec 2021 | |
Neuroblastoma | Phase 2 | KR | 02 Dec 2021 | |
Osteosarcoma, Recurrent | Phase 2 | US | 01 Jul 2015 | |
GD2 Positive Glioma | Phase 1 | US | 15 Aug 2011 | |
Small Cell Lung Cancer | Preclinical | - | - |
Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
---|
Phase 2 | 74 | Naxitamab plus GM-CSF | xsfoorsver(sujidaquia) = dtumxiyjmz mkdmrqirwm (ueqwetsmbk ) | Positive | 24 May 2024 | ||
Phase 2 | High Risk Neuroblastoma GD2 monoclonal antibodies | 74 | Naxitamab plus GM-CSF | tbqbmbfsdb(iquifsvmdv) = hqdivxolkc dnkivpqwrw (wxdzzyesnr ) View more | Positive | 24 May 2024 | |
Literature Manual | Not Applicable | 34 | lnunerpojd(kniantgyet) = hjtjidrksg fuwdvyfkwx (xtgcscnzuv ) View more | Positive | 03 Oct 2023 | ||
(early treatment) | lnunerpojd(kniantgyet) = euqmofiynm fuwdvyfkwx (xtgcscnzuv ) View more | ||||||
Phase 2 | 74 | Naxitamab 3mg/kg+GM-CSF | borabemudd(gkogxzetwc) = hypotension (58%) and pain (54%) zsvvcxyunr (rkexyrommc ) | Positive | 08 Dec 2022 | ||
NCT03363373 (ASCO2022) Manual | Phase 2 | 48 | vfupumtmpj(yjwlirtxby) = lflttjlwcg ddznbdvpyo (jccgrslccj ) View more | Positive | 02 Jun 2022 | ||
Phase 2 | 291 | gaxdyonifb(mblcscmwnj) = utmlqiyqbn zuqknwimew (nbohbulrcx, sqmoyzgurw - mawwihkjjf) View more | - | 16 May 2022 | |||
Phase 1 | 44 | Naxitamab+Yeast-Derived β-Glucan | owpafxpuxc(kjcodkbybl) = 1 pt developed transient self-limiting hepatic transaminase elevation 5 days after starting BG (120 mg/kg/day) uwpamxleyg (gukghfavln ) View more | Positive | 14 Dec 2021 | ||
Phase 2 | 48 | qnafgdrqtd(sdxukdvqri) = Anti-drug antibody formation was observed in 10/46 (22%) patients assessed ecdvubzbfx (peakhmrppu ) View more | - | 17 Sep 2021 | |||
Phase 2 | 22 | zofmbwnuuy(lsyabulkcp) = sjtanfjlpv tgvpujopyn (qovwltidgp ) | - | 28 May 2021 | |||
Not Applicable | High Risk Neuroblastoma Consolidation | 73 | ryizrnsvgr(jnnromizsu) = 2 yxkcvthbxt (iojpbkangp ) View more | Positive | 28 May 2021 |