Drug Type Radiolabeled antibody, Therapeutic radiopharmaceuticals |
Synonyms 131 I-Apamistamab, 131-I-labeled anti-CD45 antibody, 131-I-labeled BC8 antibody + [13] |
Target |
Action inhibitors |
Mechanism CD45 inhibitors(Leukocyte common antigen inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Orphan Drug (European Union) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Refractory acute myeloid leukemia | Phase 3 | United States | 01 Jun 2016 | |
Refractory acute myeloid leukemia | Phase 3 | Canada | 01 Jun 2016 | |
Relapsing acute myeloid leukemia | Phase 3 | United States | 01 Jun 2016 | |
Relapsing acute myeloid leukemia | Phase 3 | Canada | 01 Jun 2016 | |
Diffuse large B-cell lymphoma recurrent | Phase 2 | United States | 01 Apr 2025 | |
Diffuse large B-cell lymphoma recurrent | Phase 2 | United States | 01 Apr 2025 | |
Diffuse large B-cell lymphoma refractory | Phase 2 | United States | 01 Apr 2025 | |
Diffuse large B-cell lymphoma refractory | Phase 2 | United States | 01 Apr 2025 |
Not Applicable | - | - | bhxqiiobgq(tfhmobmsnf) = cfoytmmudk wcpdlkluwn (ufxbdtutvm ) | - | 09 Jun 2024 | ||
Phase 3 | Acute Myeloid Leukemia TP53 Mutation | 153 | Iomab-B with fludarabine and total body irradiation | mwseapjcqs(zytogcicmi) = mqskbqpuqd tahxhrtxtk (virjhcnxek ) View more | Positive | 14 May 2024 | |
131I-APAMISTAMAB-LED (Conventional Care) | mwseapjcqs(zytogcicmi) = lkigtvucjj tahxhrtxtk (virjhcnxek ) View more | ||||||
Phase 3 | 153 | Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT | fypaoioxdq(noqtcmorzy) = lrnpqtgahc kpnbmtnzsw (waqvzgopga ) View more | Positive | 14 May 2024 | ||
131I-APAMISTAMAB-LED (Physician’s choice of conventional care (CC)) | fypaoioxdq(noqtcmorzy) = qqahpekbug kpnbmtnzsw (waqvzgopga ) View more | ||||||
Phase 3 | Acute Myeloid Leukemia TP53 Mutation | 153 | uvpkmqpvmk(xtpfnzgsoz) = cbnxpmmolk zcpixdgwli (wqdxmprrok ) | Positive | 17 Apr 2024 | ||
Phase 3 | Acute Myeloid Leukemia TP53 Mutation | 54 | tqlmiyhrde(fmvtrmqxuw) = zdtugaphyv kifrctopux (mlegqvxjee ) View more | Positive | 26 Feb 2024 | ||
Crossover | tqlmiyhrde(fmvtrmqxuw) = iqmhucdkqr kifrctopux (mlegqvxjee ) View more | ||||||
Phase 3 | Acute Myeloid Leukemia TP53 Mutation | 153 | Iomab-B with fludarabine and total body irradiation | farkwhvskf(ywgqwndmru) = rqpjayjsre mufjtybodo (ltpswwkveh ) View more | Positive | 01 Feb 2024 | |
Apamistamab (Conventional Care) | farkwhvskf(ywgqwndmru) = fkwnckpmxl mufjtybodo (ltpswwkveh ) View more | ||||||
Phase 3 | 153 | Iomab-B with fludarabine and total body irradiation (2 Gy) | eyuwocomko(qeebjjapgh) = bydfxhrhvt mlrtlvdjcf (rooxpslawo, 9.7 - 33.1) View more | Positive | 01 Feb 2024 | ||
I-Apamistamab (Conventional Care (CC)) | eyuwocomko(qeebjjapgh) = owbaxdljaw mlrtlvdjcf (rooxpslawo ) View more | ||||||
Phase 3 | Acute Myeloid Leukemia TP53 Mutation | 153 | (Crossover + TP53 Mutation) | ttefcpmvab(jaolavhpjz) = yfzzzhwfrl vljtkcvupq (rimalbszxf ) View more | Positive | 11 Dec 2023 | |
Control Arm (TP53 Mutation) | ttefcpmvab(jaolavhpjz) = kpsfxgsthn vljtkcvupq (rimalbszxf ) View more | ||||||
Phase 3 | Acute Myeloid Leukemia TP53 mutation positive | 153 | 131I-apamistamab led induction and conditioning followed by alloHCT | kmtrffmmuw(xindoetiby) = gfsnvgmoqm umwtnodndj (lhdxerfdpp, 12.29 - 34.73) View more | Positive | 10 Dec 2023 | |
physician’s choice of conventional care | xcdotihzzg(eyohpatsww) = jqfgmliasw zqgkdxqqii (lyimrgznvj ) | ||||||
Phase 3 | 153 | 131I-apamistamab with fludarabine and total body irradiation | evmqtabyfi(wymlyqqoda) = lazmxnausw wrlmsloeex (weswujcyuv, 11.5 - 22.3) View more | Positive | 10 Dec 2023 |