Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| 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 → Apr 2027 expected | plasma cell myeloma | Pfizer | 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 | No outcome recorded |
| 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 | ||||||
| Phase 2 | NCT07247097 | Aug 2026 → Dec 2030 expected | plasma cell myeloma | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07637578 | Aug 2026 → Oct 2029 expected | plasma cell myeloma | SCRI Development Innovations, LLC | 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 | Stichting European Myeloma Network | Recruiting | No outcome recorded |
| Phase 2 | NCT06138275 | Mar 2024 → Aug 2026 overdue | 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 |
| 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 | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07647432 | Dec 2026 → Dec 2029 expected | HIV infectious disease, plasmablastic lymphoma | University of Illinois at Chicago | Not yet recruiting | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-29 | Pfizer | Pfizer’s ELREXFIO Significantly Improves Progression-Free Survival for Double-Class Exposed Patients with Relapsed or Refractory Multiple Myeloma pfizer.com ↗ |
| 2024-06-14 | Pfizer | ELREXFIO™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma pfizer.com ↗ |
| 2023-12-08 | Pfizer | European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma pfizer.com ↗ |
| 2023-08-14 | Pfizer | Pfizer’s ELREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma pfizer.com ↗ |
| 2023-02-22 | Pfizer | Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance pfizer.com ↗ |
| 2022-12-10 | Pfizer | Pfizer Presents Updated Favorable Elranatamab Data from Pivotal Phase 2 MagnetisMM-3 Trial pfizer.com ↗ |
| 2022-11-03 | Pfizer | Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma pfizer.com ↗ |
| 2021-02-17 | Pfizer | Pfizer Initiates Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab (PF-06863135) in Multiple Myeloma pfizer.com ↗ |
| 2020-12-07 | Pfizer | Pfizer Reports Positive Clinical Data for BCMA-CD3 Bispecific Antibody (PF-06863135) in Multiple Myeloma pfizer.com ↗ |
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 | “Elranatamab (Elra)” 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)” NCT04798586 ↗ “Elranatamab (PF-06863135)” NCT05462639 ↗ “Elranatamab (PF-06863135)” NCT06282978 ↗ “Elranatamab (PF-06863135)” NCT07247097 ↗ |
| 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 ↗ |