Drugs / Elranatamab

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 2/31 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
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

DateIssuerRelease
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.

FieldValueCited 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

NCT05228470

NCT05927571

NCT06988488

NCT06997081

NCT06947083

NCT07280013

NCT05675449

NCT04649359

NCT04068597

NCT06183489

NCT06207799

NCT07647432

NCT06711705

NCT06974786

NCT07474961

NCT05238311

NCT05623020

NCT05020236

NCT07247097

NCT06152575

NCT06645678

NCT06121843

NCT05014412

NCT05317416

NCT06015542

NCT07637578

NCT07382739

NCT06832865

NCT06057402

NCT06799026

NCT06918002

NCT05462639

NCT06282978

NCT06138275

NCT06106945

NCT06421675

NCT05090566

NCT06215118

NCT04798586

NCT06569147

NCT06931704

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