Drugs / Elranatamab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed relapsed/refractory diffuse large B-cell lymphoma 3 milestones | |||||
| Filed | EU (EMA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2023-02-22 | “Additionally, a marketing authorization application for ELREXFIO is currently being evaluated under the PRIME scheme by the European Medicines Agency (EMA).” pfizer.com ↗ “The European Medicines Agency (EMA) has also accepted elranatamab’s marketing authorization application (MAA).” pfizer.com ↗ |
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2023-02-22 | “The U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab” pfizer.com ↗ |
| Filed | Japan (PMDA) | ELREXFIO | relapsed/refractory diffuse large B-cell lymphoma | — | “A new drug application for ELREXFIO is being evaluated by the Japanese Ministry of Health, Labour and Welfare.” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | ELREXFIO | — | 2025-07-10 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Elrexfio | — | 2023-12-07 | europa.eu ↗ |
| Approved | US (FDA) | ELREXFIO | — | 2023-08-14 | fda.gov ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials · 1 met primary | ||||||
| Phase 1 | NCT07647432 | Dec 2026 → Dec 2029 expected | HIV infectious disease, plasmablastic lymphoma | University of Illinois at Chicago | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07280013 | Feb 2026 → Dec 2028 expected | plasma cell myeloma | C4 Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06799026 | Jan 2025 → Sep 2028 expected | plasma cell myeloma | David Avigan | Recruiting | No outcome recorded |
| Phase 1 | NCT06121843 | Feb 2024 → Aug 2028 expected | plasma cell myeloma | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting | No outcome recorded |
| Phase 1 | NCT06215118 | Feb 2024 → Nov 2027 expected | plasma cell myeloma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05927571 | Aug 2023 → Jul 2027 expected | refractory plasma cell neoplasm | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05675449 | Dec 2022 → Jul 2025 overdue | plasma cell myeloma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04798586 | Mar 2021 → May 2022 | refractory plasma cell neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03269136 | Nov 2017 → Jan 2024 | plasma cell myeloma | Pfizer | Completed | Met primary |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06645678 | Nov 2024 → Oct 2026 expected | refractory plasma cell neoplasm | YOUNGIL KOH | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06569147 | Nov 2024 → Sep 2027 expected | AL amyloidosis | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 222 trials · 1 met primary | ||||||
| Phase 2 | NCT07637578 | Sep 2026 → Oct 2029 expected | plasma cell myeloma | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07247097 | Aug 2026 → Dec 2030 expected | plasma cell myeloma | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07524634 | Jun 2026 → Jun 2031 expected | AL amyloidosis | Case Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07382739 | Mar 2026 → Dec 2028 expected | plasma cell myeloma, refractory plasma cell neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07454382 | Feb 2026 → Aug 2029 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06997081 | Sep 2025 → Sep 2030 expected | plasma cell myeloma | University of Miami | Recruiting | No outcome recorded |
| Phase 2 | NCT06832865 | Aug 2025 → Dec 2026 expected | refractory plasma cell neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06974786 | Aug 2025 → Nov 2032 expected | plasma cell myeloma | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06947083 | May 2025 → Apr 2029 expected | plasma cell myeloma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06931704 | May 2025 → Nov 2030 expected | plasma cell myeloma | Nantes University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06421675 | Mar 2025 → Dec 2026 expected | plasma cell myeloma | Ontario Clinical Oncology Group (OCOG) | Recruiting | No outcome recorded |
| Phase 2 | NCT06015542 | Jan 2025 → Dec 2026 expected | plasma cell myeloma | Thomas Lund | Recruiting | No outcome recorded |
| Phase 2 | NCT06483100 | Dec 2024 → Dec 2031 expected | plasma cell myeloma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06711705 | Dec 2024 → Dec 2029 expected | plasma cell myeloma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 2 | NCT06207799 | Jul 2024 → Dec 2029 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06183489 | May 2024 → Jul 2027 expected | smoldering plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06138275 | Mar 2024 → Dec 2027 expected | plasma cell myeloma, refractory plasma cell neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06282978 | Nov 2023 → May 2025 overdue | plasma cell myeloma | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05228470 | Dec 2021 → Aug 2023 | plasma cell myeloma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT05090566 | Oct 2021 → Feb 2025 | plasma cell myeloma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05014412 | Oct 2021 → Jun 2023 | plasma cell myeloma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04649359 | Feb 2021 → Jun 2022 overdue | plasma cell myeloma | Pfizer | Active not recruiting | Met primary |
| Phase 35 trials | ||||||
| Phase 3 | NCT06918002 | Jul 2025 → May 2036 expected | plasma cell myeloma | Intergroupe Francophone du Myelome | Recruiting | No outcome recorded |
| Phase 3 | NCT06152575 | Feb 2024 → Aug 2026 overdue | plasma cell myeloma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05623020 | Nov 2022 → Oct 2030 expected | plasma cell myeloma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05317416 | Mar 2022 → Aug 2027 expected | plasma cell myeloma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05020236 | Oct 2021 → Apr 2026 overdue | plasma cell myeloma | Pfizer | 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 | NCT06057402 | Oct 2023 → Feb 2032 expected | plasma cell myeloma | Pfizer | Recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05462639 | — | plasma cell myeloma | Pfizer | No longer available | No outcome recorded |
| — | NCT05238311 | — | plasma cell myeloma | Pfizer | No longer available | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT06988488 Background | Oct 2025 → May 2027 expected | plasma cell myeloma | Celgene Corporation | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06106945 Background | Dec 2023 → Aug 2027 expected | plasma cell myeloma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04068597 Background | Aug 2019 → Mar 2027 expected | T-cell non-Hodgkin lymphoma, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma | CellCentric Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-09-25 | C4 Therapeutics, Inc. | Results C4 Therapeutics Presents New Biomarker Data from the Cemsidomide Phase 1 Trial with Dexamethasone and Phase 1b Trial with Elranatamab (ELREXFIO®) in Relapsed/Refractory Multiple Myeloma at the 23rd International Myeloma Society (IMS) Annual Meeting c4therapeutics.com ↗
Biomarker data from the first two patients showed that cemsidomide drives the expansion and activation of CD8+ effector memory T cells as measured by elevated HLA-DR and prevents T-cell exhaustion as measured by PD-1, TIM-3 and LAG3 expression. |
| 2026-04-29 | Pfizer | Results Pfizer’s ELREXFIO Significantly Improves Progression-Free Survival for Double-Class Exposed Patients with Relapsed or Refractory Multiple Myeloma pfizer.com ↗
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression‑free survival (PFS), as assessed by blinded independent central review (BICR), versus standard-of-care daratumumab plus pomalidomide and dexamethasone (DPd). |
| 2024-12-05 | Pfizer | Results Pfizer Showcases Scientific Leadership in Breast Cancer and Blood Disorders Across More than 100 Presentations at ASH and SABCS pfizer.com ↗
A post hoc analysis of the Phase 2 MagnetisMM-3 trial continues to show deep and durable responses after longer-term follow-up of nearly three years, and these responses were also maintained with a reduction to once-monthly dosing in RRMM. |
| 2024-06-14 | Pfizer | Results ELREXFIO™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma pfizer.com ↗
The study demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial. |
| 2023-12-08 | Pfizer | Regulatory European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO ® (elranatamab). |
| 2023-08-14 | Pfizer | Regulatory Pfizer’s ELREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma pfizer.com ↗
The approval of ELREXFIO (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study |
| 2023-02-22 | Pfizer | Regulatory Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance pfizer.com ↗
The European Medicines Agency (EMA) has also accepted elranatamab’s marketing authorization application (MAA). |
| 2022-12-10 | Pfizer | Results Pfizer Presents Updated Favorable Elranatamab Data from Pivotal Phase 2 MagnetisMM-3 Trial pfizer.com ↗
Results showed early and deep responses, and a manageable safety profile for elranatamab in heavily pretreated patients with advanced multiple myeloma |
| 2022-11-03 | Pfizer | Regulatory Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM). |
| 2020-12-07 | Pfizer | Results Pfizer Reports Positive Clinical Data for BCMA-CD3 Bispecific Antibody (PF-06863135) in Multiple Myeloma pfizer.com ↗
Data from 30 patients with relapsed or refractory multiple myeloma showed manageable safety across all subcutaneous dose levels with no dose-limiting toxicities observed, and 83% of patients achieved a clinical response at the highest dose level. |
All press releases naming this drug 12 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elranatamab | “Elranatamab is a type of drug called a bispecific antibody that connects a B cell maturation antigen (BCMA), a protein on plasma cells, with CD3, a protein on T cells.” NCT07524634 ↗43“Elranatamab, a bispecific antibody, engages BCMA on MM and CD3 on T cells.” PMID 37783970 ↗ Oct 2023 “Elranatamab will be dosed in 28-day cycles as follows:” NCT06483100 ↗ |
| Known as | Elra | “This is a single-arm feasibility trial in which patients with histologically confirmed plasmablastic lymphoma (PBL) with or without HIV, who have achieved a Complete Response...” NCT07647432 ↗ |
| Known as | Elranatamab-bcmm | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07454382 ↗ |
| Known as | Elrexfio | “Elranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.” NCT06421675 ↗ |
| Known as | PF-06863135 | “AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB +...” NCT05623020 ↗8“A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN...” NCT05014412 ↗ “The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma.” NCT04649359 ↗ “study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma.” NCT05228470 ↗ “Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)” NCT05238311 ↗ “Elranatamab (PF-06863135)” NCT07247097 ↗ “Elranatamab (PF-06863135)” NCT04798586 ↗ “Elranatamab (PF-06863135)” NCT05462639 ↗ “Elranatamab (PF-06863135)” NCT06282978 ↗ |
| Known as | RN-613 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297809 ↗ |
| Action | Deplete | “The drug then activates T-cells to kill the myeloma cells.” NCT06138275 ↗ |
| Modality | Monoclonal antibody | “BCMA-CD3 bispecific antibody” NCT05228470 ↗ |
| Route | Subcutaneous | “patients with relapsed or refractory multiple myeloma received subcutaneous elranatamab once weekly after two step-up priming doses.” PMID 37582952 ↗ Aug 2023 |
| Target | TNFRSF17 | “Tumor necrosis factor receptor superfamily member 17 binding agent” CHEMBL4297809 ↗ |