Drugs / Linvoseltamab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 4 milestones | |||||
| Filed | US (FDA) | — | plasma cell myeloma | 2025-04-29 | “The FDA accepted for review the resubmission of the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in R/R multiple myeloma” regeneron.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | 2025-01-13 | “In January 2025, the Company resubmitted to the FDA the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in relapsed/refractory (R/R) multiple myeloma” regeneron.com ↗ “The linvoseltamab BLA has been resubmitted following resolution of third-party manufacturing issues, with launch anticipated in mid-2025.” regeneron.com ↗ “A BLA for linvoseltamab in relapsed/refractory multiple myeloma was submitted to the FDA in December 2023” regeneron.com ↗ “Earlier this month, the FDA accepted for review the Biologics License Application for linvoseltamab.” regeneron.com ↗ |
| Rejected (CRL) | US (FDA) | — | plasma cell myeloma | 2024-08-20 | “FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma” regeneron.com ↗ |
| Filed | EU (EMA) | — | plasma cell myeloma | — | “Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.” regeneron.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2024-02-02 | “European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R)...” regeneron.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Lynozyfic | — | 2025-04-23 | europa.eu ↗ |
Trials 22
| 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 Stop: Business |
| Phase 35 trials | ||||||
| Phase 3 | NCT07624513 | Aug 2026 → Oct 2033 expected | plasma cell myeloma | Dana-Farber Cancer Institute | 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 | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT05164250 Background | — | plasma cell myeloma | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Regeneron Pharmaceuticals | Results Lynozyfic® (linvoseltamab) Monotherapy Demonstrates Deep and Rapid Responses in All Treated Patients with Second-Line-Plus Systemic Amyloid Light Chain Amyloidosis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from the Phase 1/2 LINKER-AL2 trial evaluating Lynozyfic® (linvoseltamab) in adults with second-line-plus systemic amyloid light chain (AL) amyloidosis, which will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting on Friday, May 29 at 2:45 p.m. CDT. |
| 2025-12-07 | Regeneron Pharmaceuticals | Results Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment regeneron.com ↗
All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time |
| 2025-07-02 | Regeneron Pharmaceuticals | Regulatory Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma regeneron.com ↗
Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. |
| 2025-05-22 | Regeneron Pharmaceuticals | Results Linvoseltamab in Combination with Carfilzomib or Bortezomib Shows Promising Initial Results in Earlier Lines of Treatment for Relapsed/Refractory Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with relapsed/refractory (R/R) multiple myeloma (MM). |
| 2025-04-28 | Regeneron Pharmaceuticals | Regulatory Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). |
| 2025-02-28 | Regeneron Pharmaceuticals | Regulatory Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). |
| 2025-02-11 | Regeneron Pharmaceuticals | Regulatory Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma regeneron.com ↗ |
| 2025-01-13 | Regeneron Pharmaceuticals | Regulatory Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference regeneron.com ↗
The linvoseltamab BLA has been resubmitted following resolution of third-party manufacturing issues, with launch anticipated in mid-2025. |
| 2024-08-20 | Regeneron Pharmaceuticals | Regulatory Regeneron Provides Update on Biologics License Application for Linvoseltamab regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. |
| 2024-06-16 | Regeneron Pharmaceuticals | Results Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma regeneron.com ↗
At 14-months median follow-up in the pivotal trial, 50% of patients achieved a complete response or better and a 71% overall response rate, as presented in an EHA oral presentation and simultaneously published in the Journal of Clinical Oncology |
| 2024-04-07 | Regeneron Pharmaceuticals | Results Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma regeneron.com ↗
In clinical trials, linvoseltamab treatment led to responses that occurred early, were durable and deepened over time – all critical efficacy measures for this heavily pre-treated patient population. |
| 2024-02-21 | Regeneron Pharmaceuticals | Regulatory Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. |
| 2024-02-02 | Regeneron Pharmaceuticals | Regulatory Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies. |
| 2023-12-07 | Regeneron Pharmaceuticals | Results Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM). |
| 2023-05-25 | Regeneron Pharmaceuticals | Results Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma regeneron.com ↗
Treatment with linvoseltamab at the recommended 200 mg dose in the LINKER-MM1 trial demonstrated impressive efficacy, with rapid, deep and durable responses in patients with multiple myeloma that’s highly refractory to standard therapies. |
| 2021-12-11 | Regeneron Pharmaceuticals | Results New REGN5458 (BCMAxCD3) Phase 1 Data Show 75% Response Rate at Highest Dose Levels Studied in Patients with Heavily Pretreated Multiple Myeloma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new results for higher dose level cohorts of its investigational REGN5458 (BCMAxCD3) bispecific antibody, which were presented in an oral session at the 2021 American Society of Hematology (ASH) Annual Meeting in Atlanta, GA. |
| 2020-12-05 | Regeneron Pharmaceuticals | Results Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. |
| 2019-12-08 | Regeneron Pharmaceuticals | Results First Clinical Data for REGN5458 (BCMAxCD3) Show Positive Preliminary Results in Multiple Myeloma regeneron.com ↗
Responses were observed in 4 of 7 (57%) patients, including 3 of 4 (75%) in the 6 mg dose group. |
All press releases naming this drug 19 releases
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 ↗ |