Drugs / Linvoseltamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Lynozyfic | — | 2025-04-23 | europa.eu ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06369467 | May 2024 → Aug 2027 expected | food allergy | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT07455851 | Mar 2026 → Sep 2033 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07181941 | Mar 2026 → Jun 2028 expected | plasma cell myeloma | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06669247 | Dec 2024 → Nov 2033 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06292780 | Aug 2024 → Aug 2028 expected | AL amyloidosis | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05828511 | Dec 2023 → Nov 2035 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03761108 | Jan 2019 → Mar 2033 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07009899 | Jul 2026 → Feb 2028 expected | plasma cell myeloma | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07053436 | Apr 2026 → Oct 2035 expected | — | Multiple Myeloma Research Consortium | Recruiting | No outcome recorded |
| Phase 2 | NCT06910124 | Dec 2025 → Dec 2032 expected | plasma cell myeloma | Dickran Kazandjian, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06140524 | Sep 2024 → May 2032 expected | monoclonal gammopathy of uncertain significance, smoldering plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06376526 | Aug 2024 → Aug 2027 expected | plasma cell myeloma | Dickran Kazandjian, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05955508 | Jan 2024 → Jan 2033 expected | smoldering plasma cell myeloma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07428369 | Jun 2026 → May 2038 | plasma cell myeloma | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07624513 | Jun 2026 → Oct 2033 expected | plasma cell myeloma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07393282 | May 2026 → Jul 2033 expected | smoldering plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07222761 | Jan 2026 → May 2029 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06932562 | Dec 2025 → Dec 2036 expected | plasma cell myeloma | European Myeloma Network B.V. | Recruiting | No outcome recorded |
| Phase 3 | NCT05730036 | Sep 2023 → Apr 2033 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07474961 | Mar 2027 → Dec 2036 expected | Waldenstrom macroglobulinemia, plasma cell myeloma | Anne Louise Tølbøll Sørensen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07609940 | Jul 2026 → Oct 2027 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05164250 Background | — | plasma cell myeloma | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
Press releases naming this drug 18 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Regeneron Pharmaceuticals | Lynozyfic® (linvoseltamab) Monotherapy Demonstrates Deep and Rapid Responses in All Treated Patients with Second-Line-Plus Systemic Amyloid Light Chain Amyloidosis regeneron.com ↗ |
| 2025-12-07 | Regeneron Pharmaceuticals | Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment regeneron.com ↗ |
| 2025-07-02 | Regeneron Pharmaceuticals | Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma regeneron.com ↗ |
| 2025-05-22 | Regeneron Pharmaceuticals | Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma regeneron.com ↗ |
| 2025-05-01 | Regeneron Pharmaceuticals | Regeneron to Highlight Advances at ASCO with Phase 3 Adjuvant Libtayo® (cemiplimab) CSCC Updates and Promising Early Blood Cancer Data with Linvoseltamab Combination regeneron.com ↗ |
| 2025-04-28 | Regeneron Pharmaceuticals | Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma regeneron.com ↗ |
| 2025-02-28 | Regeneron Pharmaceuticals | Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma regeneron.com ↗ |
| 2025-02-11 | Regeneron Pharmaceuticals | Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma regeneron.com ↗ |
| 2024-08-20 | Regeneron Pharmaceuticals | Regeneron Provides Update on Biologics License Application for Linvoseltamab regeneron.com ↗ |
| 2024-06-16 | Regeneron Pharmaceuticals | Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma regeneron.com ↗ |
| 2024-04-07 | Regeneron Pharmaceuticals | Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma regeneron.com ↗ |
| 2024-02-21 | Regeneron Pharmaceuticals | Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review regeneron.com ↗ |
| 2024-02-02 | Regeneron Pharmaceuticals | Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma regeneron.com ↗ |
| 2023-12-07 | Regeneron Pharmaceuticals | Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma regeneron.com ↗ |
| 2023-05-25 | Regeneron Pharmaceuticals | Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma regeneron.com ↗ |
| 2021-12-11 | Regeneron Pharmaceuticals | New REGN5458 (BCMAxCD3) Phase 1 Data Show 75% Response Rate at Highest Dose Levels Studied in Patients with Heavily Pretreated Multiple Myeloma regeneron.com ↗ |
| 2020-12-05 | Regeneron Pharmaceuticals | Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1 regeneron.com ↗ |
| 2019-12-08 | Regeneron Pharmaceuticals | First Clinical Data for REGN5458 (BCMAxCD3) Show Positive Preliminary Results in Multiple Myeloma regeneron.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linvoseltamab | “Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy” NCT07053436 ↗ |
| Known as | REGN5458 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05164250 ↗ |
| Action | Deplete | “how well linvoseltamab eliminates plasma cells” NCT05955508 ↗ |
| Modality | Monoclonal antibody | “a BCMA × CD3 bispecific antibody” PMID 41387038 ↗ Nov 2025 |
| Route | Intravenous | “linvoseltamab intravenous (IV) dose escalation” NCT03761108 ↗ |