Drug · Monoclonal Antibody
Linvoseltamab
CI-DRUG-00000813Explore in graph →CHEMBL5095373 Phase 3
Regulatory
Approvals (1)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Multiple Myeloma | Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.conditional | approved | Apr 23, 2025 | ema |
Data updated 14 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 18 | 15 | 6 | 19 | 1 | EU | Apr 23, 2025 | Jan 23, 2019 |
| Multiple Myeloma | Approved | Phase 3 | 14 | 11 | 4 | 15 | 1 | EU | Apr 23, 2025 | Jan 23, 2019 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 14 | 11 | 4 | 15 | 1 | EU | Apr 23, 2025 | Jan 23, 2019 |
ComputedclinicaltrialsProvenance
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (20)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07393282 | A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)(LINKER-SMM2) | recruiting | Phase 3 | 270 | Regeneron PharmaceuticalsINDUSTRY | 4 | Sep 25, 2026 | clinicaltrials |
| NCT07609940 | Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS) |