Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms BCMAxCD3 antibody, BCMAxCD3 bispecific antibody(Regeneron Pharmaceuticals, Inc.), Linvoseltamab + [5] |
Target |
Action inhibitors, stimulants |
Mechanism BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (23 Apr 2025), |
RegulationPriority Review (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (European Union) |



| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12222 | - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Refractory Multiple Myeloma | European Union | 23 Apr 2025 | |
| Refractory Multiple Myeloma | Iceland | 23 Apr 2025 | |
| Refractory Multiple Myeloma | Liechtenstein | 23 Apr 2025 | |
| Refractory Multiple Myeloma | Norway | 23 Apr 2025 | |
| Relapse multiple myeloma | European Union | 23 Apr 2025 | |
| Relapse multiple myeloma | Iceland | 23 Apr 2025 | |
| Relapse multiple myeloma | Liechtenstein | 23 Apr 2025 | |
| Relapse multiple myeloma | Norway | 23 Apr 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Smoldering Multiple Myeloma | Phase 3 | United States | 21 May 2026 | |
| Smoldering Multiple Myeloma | Phase 3 | Japan | 21 May 2026 | |
| Smoldering Multiple Myeloma | Phase 3 | South Korea | 21 May 2026 | |
| Multiple Myeloma | Phase 3 | Australia | 23 Dec 2025 | |
| Multiple Myeloma | Phase 3 | Austria | 23 Dec 2025 | |
| Multiple Myeloma | Phase 3 | Croatia | 23 Dec 2025 | |
| Multiple Myeloma | Phase 3 | Czechia | 23 Dec 2025 | |
| Multiple Myeloma | Phase 3 | Denmark | 23 Dec 2025 | |
| Multiple Myeloma | Phase 3 | Estonia | 23 Dec 2025 | |
| Multiple Myeloma | Phase 3 | Finland | 23 Dec 2025 |
Phase 1/2 | 234 | (High-Risk Smoldering Multiple Myeloma) | yyftryccfs(fjzpvncicz) = lqpbritaue csdfgibhwa (ayojxgkhwm ) View more | Positive | 29 May 2026 | ||
Phase 3 | Multiple Myeloma First line | 360 | DRd induction followed by Linvoseltamab | jztzolwmmc(zkduxyhtiv) = zqfpbdmubx grreetiyaf (zmfepiqjlw ) View more | Positive | 12 May 2026 | |
DRd | kpsxqyllfw(hnaaodsrrn) = tnrpcnvfhx hqeeiqdzur (ywkfoaqvxf ) View more | ||||||
Phase 1/2 | Multiple Myeloma First line | 45 | Linvoseltamab 50 mg | lyzzciwmlm(asvrdsczqr) = A single immune effector cell-associated neurotoxicity syndrome (ICANS) event was observed and resolved (Gr 1: 50 mg). thuasmjtfg (vnzlwwvwzx ) View more | Positive | 06 Dec 2025 | |
Phase 3 | 117 | yesroyzrlk(cojmcootpo) = yrjdtukknw kqxpieayqj (uwesujdzkp ) View more | Positive | 01 Nov 2025 | |||
Phase 1 | 23 | ojeijqjhme(csslxniwlj) = One pt experienced ICANS (Gr 1). Infections were reported in 91% of pts (Gr ≥3 43%). One DLT was observed at DL1, Gr 4 thrombocytopenia during tumor lysis syndrome, which was fully resolved and tx resumed at the same dose. otsgulybce (yvxdubeyjz ) View more | Positive | 17 Sep 2025 | |||
Phase 3 | 117 | ltfdyykmns(zebgoikdfs): OR = 0.67 (95.0% CI, 0.4 - 1.15) View more | Positive | 17 Sep 2025 | |||
Phase 2 | 24 | cclluaofqz(tctawkxuiv) = ypppfuoeii lghopifzda (knsgziylvz ) View more | Positive | 17 Sep 2025 | |||
Phase 1/2 | 117 | ltdamavgcg(kfdxxnmykx) = ewbsomnqop lwaabsfvss (ulwxgfifyk ) View more | Positive | 17 Sep 2025 | |||
Phase 2 | 117 | (Frail + IMWG-FP) | dcdbjedoiu(rcogoyzwmv) = whonoxakrs izwxydqhkg (rvodlakxyl ) View more | Positive | 17 Sep 2025 | ||
(Non-frail + IMWG-FP) | dcdbjedoiu(rcogoyzwmv) = osghyvyekn izwxydqhkg (rvodlakxyl ) View more | ||||||
Phase 1/2 | 117 | nflvhcakqc(optsjukxzv) = qakrqleiuo ysozlsareu (miaynnwwwp ) View more | Positive | 17 Sep 2025 |






