Elranatamab History and Updates

157 events · 2019 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

7
FDA Approvals
1
Label Revisions
149
Trial Milestones
0
Pivotal Publications
Elranatamab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202020212022202320242025202620272028202920302031203220332034203520362037Trial: NCT07474961 2027-03-31 → 2036-12-31 (primary completion)Trial: NCT07637578 2026-08-31 → 2029-10-31 (primary completion)Trial: NCT07247097 2026-04-15 → 2030-12-01 (primary completion)Trial: NCT07382739 2026-03-31 → 2028-12-31 (primary completion)Trial: NCT07454382 2026-02-27 → 2029-08-27 (primary completion)Trial: NCT07280013 2026-02-06 → 2028-12-31 (primary completion)Trial: NCT07320326 2025-12-30 → 2028-07-18 (primary completion)Trial: NCT06988488 2025-10-07 → 2027-05-31 (primary completion)Trial: NCT06997081 2025-09-16 → 2030-09-30 (primary completion)Trial: NCT06832865 2025-08-14 → 2026-12-01 (primary completion)Trial: NCT06974786 2025-08-08 → 2032-11-30 (primary completion)Trial: NCT06918002 2025-07-09 → 2036-05-31 (primary completion)Trial: NCT06581848 2025-06-05 → 2030-01-31 (primary completion)Trial: NCT06947083 2025-05-27 → 2029-04-30 (primary completion)Trial: NCT06931704 2025-05-01 → 2030-11-30 (primary completion)Trial: NCT06421675 2025-03-28 → 2026-12-31 (primary completion)Trial: NCT06799026 2025-01-31 → 2028-09-01 (primary completion)Trial: NCT06015542 2025-01-29 → 2026-12-01 (primary completion)Trial: NCT06855121 2025-01-15 → 2029-01-31 (primary completion)Trial: NCT06711705 2024-12-18 → 2029-12-31 (primary completion)Trial: NCT06645678 2024-11-26 → 2026-10-01 (primary completion)Trial: NCT06569147 2024-11-01 → 2027-09-01 (primary completion)Trial: NCT06592222 2024-08-26 → 2025-03-03 (primary completion)Trial: NCT06207799 2024-07-17 → 2029-12-31 (primary completion)Trial: NCT06183489 2024-05-14 → 2027-07-31 (primary completion)Trial: NCT06138275 2024-03-08 → 2026-08-01 (primary completion)Trial: NCT06121843 2024-02-22 → 2028-08-01 (primary completion)Trial: NCT06215118 2024-02-20 → 2027-04-10 (primary completion)Trial: NCT06152575 2024-02-08 → 2026-08-30 (primary completion)Trial: NCT06106945 2023-12-05 → 2027-08-16 (primary completion)Trial: NCT06282978 2023-11-23 → 2025-05-31 (primary completion)Trial: NCT06057402 2023-10-03 → 2032-02-22 (primary completion)Trial: NCT06504524 2023-09-01 → 2024-05-31 (primary completion)Trial: NCT05927571 2023-08-10 → 2027-07-31 (primary completion)Trial: NCT05932290 2023-06-01 → 2023-07-12 (primary completion)Trial: NCT05675449 2022-12-14 → 2025-07-07 (primary completion)Trial: NCT05623020 2022-11-10 → 2030-10-18 (primary completion)Trial: NCT05565391 2022-10-03 → 2022-11-04 (primary completion)Trial: NCT05317416 2022-03-25 → 2027-08-04 (primary completion)Trial: NCT05228470 2021-12-21 → 2023-08-06 (primary completion)Trial: NCT05090566 2021-10-27 → 2025-02-13 (primary completion)Trial: NCT05014412 2021-10-07 → 2023-06-15 (primary completion)Trial: NCT05020236 2021-10-04 → 2026-04-27 (primary completion)Trial: NCT04798586 2021-03-22 → 2022-05-27 (primary completion)Trial: NCT04649359 2021-02-02 → 2022-06-17 (primary completion)Trial: NCT04068597 2019-08-09 → 2027-03-31 (primary completion)FDA approval — 2023-08-14 FDA approved Elrexfio (elranatamab-bcmm) (BLA 761345) Sponsor: PFIZER INC. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2023-12-13 FDA approved supplemental application for Elrexfio (elranatamab-bcmm) — REMS (BLA 761345 S-1) Sponsor: PFIZER INC. Class: REMS.FDA approval (supplemental) — 2024-09-10 FDA approved supplemental application for Elrexfio (elranatamab-bcmm) — REMS (BLA 761345 S-2) Sponsor: PFIZER INC. Class: REMS.FDA approval (supplemental) — 2025-07-08 FDA approved supplemental application for Elrexfio (elranatamab-bcmm) — Labeling (BLA 761345 S-4) Sponsor: PFIZER INC. Class: Labeling.FDA approval (supplemental) — 2025-07-10 FDA approved supplemental application for Elrexfio (elranatamab-bcmm) — Efficacy (BLA 761345 S-3) Sponsor: PFIZER INC. Class: Efficacy.FDA approval (supplemental) — 2026-02-19 FDA approved supplemental application for Elrexfio (elranatamab-bcmm) — Labeling (BLA 761345 S-7) Sponsor: PFIZER INC. Class: Labeling.FDA approval (supplemental) — 2026-03-25 FDA approved supplemental application for Elrexfio (elranatamab-bcmm) — REMS (BLA 761345 S-9) Sponsor: PFIZER INC. Class: REMS.Label revision — 2026-05-14 Boxed warning present on label on Elrexfio label (effective 2026-05-14) WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME • Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELResults posted — 2023-10-25 Trial results posted: NCT04649359 MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, OnResults posted — 2024-04-22 Trial results posted: NCT05565391 A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple MyelomaResults posted — 2024-07-30 Trial results posted: NCT05014412 A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to TreatmeResults posted — 2024-09-19 Trial results posted: NCT05228470 A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.Results posted — 2024-09-27 Trial results posted: NCT04798586 MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple MyelomaResults posted — 2024-10-29 Trial results posted: NCT05932290 A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple MyelomaResults posted — 2025-06-27 Trial results posted: NCT06504524 A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany Results posted — 2026-02-23 Trial results posted: NCT05090566 MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myelomatoday (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Elranatamab since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (5)

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Ta
Trial started· ClinicalTrials.gov
A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Mu
Primary completion· ClinicalTrials.gov
A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With
Primary completion· ClinicalTrials.gov
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed
Primary completion· ClinicalTrials.gov
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
Primary completion· ClinicalTrials.gov
ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participa
Primary completion· ClinicalTrials.gov
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refract
Primary completion· ClinicalTrials.gov
A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Ext
Primary completion· ClinicalTrials.gov
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Primary completion· ClinicalTrials.gov
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Le
Primary completion· ClinicalTrials.gov
Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly
Primary completion· ClinicalTrials.gov
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
Primary completion· ClinicalTrials.gov
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification t
Primary completion· ClinicalTrials.gov
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible N

Past events

2026
Primary completion· ClinicalTrials.gov
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Tre
Trial started· ClinicalTrials.gov
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
Trial started· ClinicalTrials.gov
A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Ext
Results posted· ClinicalTrials.gov
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
2025
Trial started· ClinicalTrials.gov
ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab
Trial started· ClinicalTrials.gov
A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With
Trial started· ClinicalTrials.gov
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification t
Trial started· ClinicalTrials.gov
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible N
Primary completion· ClinicalTrials.gov
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multi
Results posted· ClinicalTrials.gov
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany
Trial started· ClinicalTrials.gov
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Primary completion· ClinicalTrials.gov
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
Primary completion· ClinicalTrials.gov
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
Trial started· ClinicalTrials.gov
Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly
Primary completion· ClinicalTrials.gov
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared
Primary completion· ClinicalTrials.gov
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
Trial started· ClinicalTrials.gov
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refract
2024
Results posted· ClinicalTrials.gov
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma
Results posted· ClinicalTrials.gov
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
Results posted· ClinicalTrials.gov
A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Trial started· ClinicalTrials.gov
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared
Results posted· ClinicalTrials.gov
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatme
Trial started· ClinicalTrials.gov
Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany
Results posted· ClinicalTrials.gov
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participa
Trial started· ClinicalTrials.gov
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Mu
Trial started· ClinicalTrials.gov
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Ta
2023
Trial started· ClinicalTrials.gov
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
Results posted· ClinicalTrials.gov
MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, On
Trial started· ClinicalTrials.gov
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany
Trial started· ClinicalTrials.gov
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed
Primary completion· ClinicalTrials.gov
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatme
Trial started· ClinicalTrials.gov
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma
2022
Trial started· ClinicalTrials.gov
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multi
Trial started· ClinicalTrials.gov
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Le
Primary completion· ClinicalTrials.gov
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Primary completion· ClinicalTrials.gov
MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, On
Trial started· ClinicalTrials.gov
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
2021
Trial started· ClinicalTrials.gov
A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Trial started· ClinicalTrials.gov
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
Trial started· ClinicalTrials.gov
A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatme
Trial started· ClinicalTrials.gov
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Tre
Trial started· ClinicalTrials.gov
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma
Trial started· ClinicalTrials.gov
MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, On
2020
2019

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.