Drugs / Belantamab mafodotin
Belantamab mafodotin
also known as
GSK2857916 · belamaf · BLENREP · Belantamab mafodotin blmf · Belantamab mafodotina · Belantamab mafodotine
Monoclonal antibody targets TNFRSF17
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 1 milestone | |||||
| Filed | US (FDA) | Blenrep | plasma cell myeloma | 2024-11-25 | “the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep” gsk.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 5 milestones | |||||
| Filed | China (NMPA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | 2024-12-09 | “the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep” gsk.com ↗ |
| Filed | EU (EMA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | 2024-07-19 | “the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep” gsk.com ↗ |
| Filed | EU (EMA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2020-02-03 | “the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for belantamab mafodotin” gsk.com ↗ |
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2019-12-16 | “GSK also confirmed submission of a Biologics License Application to the US Food and Drug Administration (FDA) seeking approval of belantamab mafodotin” gsk.com ↗ |
| Filed | UK (MHRA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | — | “marketing authorisation application acceptance2 by the European Medicines Agency (EMA) in July 2024 and by the Medicines and Healthcare products Regulatory Agency” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Blenrep | — | 2020-08-25 | europa.eu ↗ |
Trials 69 · started per year
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EU approved 2020
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT07831122 | Dec 2026 → Jan 2033 expected | refractory plasma cell neoplasm | Canadian Myeloma Research Group | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07609706 | Oct 2026 → Aug 2031 expected | plasma cell myeloma | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05065047 | Jan 2023 → Nov 2025 | plasma cell myeloma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT05556798 | Oct 2022 → Oct 2026 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05055063 | May 2022 → Feb 2027 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04892264 | Jun 2021 → Mar 2024 | plasma cell myeloma | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04398680 | Apr 2021 → Nov 2025 | plasma cell myeloma | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04398745 | Oct 2020 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04091126 | Dec 2019 → Jun 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04177823 | Dec 2019 → Dec 2021 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT03828292 | Mar 2019 → Apr 2023 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02064387 | Jul 2014 → Aug 2018 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/228 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07612787 | Dec 2026 → Jan 2028 expected | plasma cell myeloma | University Hospital of Saint-Etienne | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06232044 | Apr 2025 → May 2028 | plasma cell myeloma | Alliance for Clinical Trials in Oncology | Suspended | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05145816 | Feb 2024 → Mar 2027 expected | AL amyloidosis | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05573802 | Jul 2023 → Oct 2026 expected | corneal disorder, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05853965 | Jun 2023 → Apr 2027 expected | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05714839 | Jun 2023 → Aug 2028 expected | plasma cell myeloma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05493618 | Dec 2022 → Nov 2025 | plasma cell myeloma | Hackensack Meridian Health | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05581875 | Oct 2022 → Oct 2026 expected | corneal disorder, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07150104 | Aug 2022 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT07150091 | Jul 2022 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05280275 | Apr 2022 → Mar 2026 | corneal disorder, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 1/2 | NCT05002816 | Feb 2022 → Jan 2026 overdue | plasma cell myeloma | Yale University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05060627 | Dec 2021 → Oct 2024 overdue | plasma cell myeloma | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04896658 | Dec 2021 → Jun 2023 | refractory plasma cell neoplasm | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT07217184 | Jul 2021 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04822337 | May 2021 → Apr 2029 expected | plasma cell myeloma | Wake Forest University Health Sciences | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06655818 | Mar 2021 → Feb 2024 | refractory plasma cell neoplasm | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1/2 | NCT04808037 | Feb 2021 → Sep 2028 expected | plasma cell myeloma | Hellenic Society of Hematology | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04643002 | Jan 2021 → Sep 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07084896 | Jun 2020 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT07217119 | Nov 2019 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06160609 | Oct 2019 → Jan 2023 | refractory plasma cell neoplasm | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1/2 | NCT04126200 | Oct 2019 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03732703 | Apr 2019 → Dec 2024 | refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT03848845 | Mar 2019 → Oct 2021 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT03715478 | Nov 2018 → Jun 2025 overdue | refractory plasma cell neoplasm | Canadian Myeloma Research Group | Active not recruiting | Met primary |
| Phase 1/2 | NCT03544281 | Sep 2018 → Feb 2023 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT02343042 | Oct 2015 → Apr 2027 expected | plasma cell myeloma | Karyopharm Therapeutics Inc | Recruiting | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07844200 | Feb 2027 → Feb 2030 expected | systemic lupus erythematosus | Medical Association for the Study of Cancer Biology and Treatment | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05874193 | Nov 2026 → Oct 2028 | refractory plasma cell neoplasm | Cristiana Costa Chase, DO | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT07614360 | Aug 2026 → Feb 2029 expected | plasma cell myeloma | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07224672 | Jun 2026 → Jan 2033 expected | AL amyloidosis | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT07227311 | Apr 2026 → Aug 2030 expected | plasma cell myeloma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT07019545 | Jun 2025 → Jun 2026 overdue | autoimmune thrombocytopenia | Hellenic Society of Hematology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04876248 | Aug 2024 → Jul 2027 expected | plasma cell myeloma | Roswell Park Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05922501 | May 2024 → Dec 2028 expected | plasma cell myeloma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05847569 | Jan 2024 → Jun 2029 expected | plasma cell myeloma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05789303 | May 2023 → Jul 2028 expected | plasma cell myeloma | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT05091372 | Dec 2022 → Dec 2027 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05208307 | Jul 2022 → Oct 2027 expected | plasma cell myeloma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT05117008 | Jul 2022 → Jan 2024 | refractory plasma cell neoplasm | Medical College of Wisconsin | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05064358 | Mar 2022 → Aug 2024 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04676360 | Jul 2021 → Nov 2023 | ALK-positive large B-cell lymphoma, plasmablastic lymphoma | Jacob Soumerai, MD | Terminated | No outcome recorded |
| Phase 2 | NCT04680468 | Jun 2021 → Jul 2026 overdue | plasma cell myeloma | University of Pennsylvania | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04802356 | Apr 2021 → Mar 2025 overdue | plasma cell myeloma | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04617925 | Feb 2021 → Jul 2025 | AL amyloidosis | Stichting European Myeloma Network | Completed | No outcome recorded |
| Phase 2 | NCT03525678 | Jun 2018 → Jun 2019 | plasma cell myeloma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 39 trials · 3 met primary · 2 missed | ||||||
| Phase 3 | NCT07285239 | Jul 2026 → Nov 2031 expected | plasma cell myeloma | PrECOG, LLC. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06679101 | Dec 2024 → Apr 2031 expected | plasma cell myeloma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06956170 | Feb 2022 → May 2024 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Missed primary |
| Phase 3 | NCT06868667 | Jul 2021 → Apr 2024 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06868654 | Jul 2021 → Apr 2024 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Met primary |
| Phase 3 | NCT04549363 | Dec 2020 → Nov 2022 | plasma cell myeloma | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT04484623 | Oct 2020 → Jan 2024 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Met primary |
| Phase 3 | NCT04246047 | May 2020 → Oct 2023 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Met primary |
| Phase 3 | NCT04162210 | Apr 2020 → Sep 2022 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT03763370 | — | plasma cell myeloma | GlaxoSmithKline | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT05461209 Comparator | Oct → Nov 2022 | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-05-26 | GlaxoSmithKline | Results GSK to showcase long-term outcomes and pipeline expansion with latest oncology research at ASCO and EHA gsk.com ↗
Four-year results from DREAMM-7 will show long-term efficacy, including overall survival, depth of response and health-related quality of life, reinforcing belantamab mafodotin with bortezomib and dexamethasone as a potential new standard of care in RRMM (EHA abstract #PS1862). |
| 2026-04-20 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) approved in China for treatment of 2L+ relapsed/refractory multiple myeloma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the National Medical Products Administration (NMPA) of China has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. |
| 2025-10-23 | GlaxoSmithKline | Regulatory Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma gsk.com ↗
Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients. |
| 2025-07-24 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma gsk.com ↗ |
| 2025-07-23 | GlaxoSmithKline | Regulatory GSK announces extension of US Food and Drug Administration review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma gsk.com ↗
The new Prescription Drug User Fee Act (PDUFA) action date is 23 October 2025 and provides the FDA with time to review additional information provided in support of the application. |
| 2025-07-17 | GlaxoSmithKline | Regulatory GSK provides update on US FDA advisory committee review of Blenrep (belantamab mafodotin-blmf) combinations for patients with relapsed/refractory multiple myeloma gsk.com ↗ |
| 2025-05-29 | GlaxoSmithKline | Results GSK data at ASCO and EHA showcase latest research and innovation across the oncology portfolio gsk.com ↗
DREAMM-8 data shows the association of measurable residual disease (MRD) negativity with efficacy endpoints (ASCO abstract #7515). |
| 2025-05-23 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma gsk.com ↗ |
| 2025-05-19 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple myeloma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the approval of Blenrep combinations by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with relapsed or refractory multiple myeloma. |
| 2025-04-17 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma gsk.com ↗
In the UK, Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. |
| 2024-12-09 | GlaxoSmithKline | Results Blenrep shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse gsk.com ↗
DREAMM-7 trial shows sustained overall survival benefit for Blenrep (belantamab mafodotin) combination versus daratumumab combination; benefit seen early and maintained through follow-up |
| 2024-12-09 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) as a treatment for relapsed or refractory multiple myeloma. |
| 2024-11-25 | GlaxoSmithKline | Regulatory Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma gsk.com ↗
The US FDA has assigned a Prescription Drug User Fee Act action date of 23 July 2025. |
| 2024-11-14 | GlaxoSmithKline | Results Blenrep shows overall survival benefit in head-to-head DREAMM-7 phase III trial for relapsed/refractory multiple myeloma gsk.com ↗
The trial met the key secondary endpoint of overall survival (OS), showing that belantamab mafodotin when combined with BorDex significantly reduced the risk of death versus standard of care daratumumab plus BorDex. |
| 2024-09-17 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple myeloma accepted for regulatory review in Japan gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma. |
| 2024-09-13 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) in combination receives Breakthrough Therapy Designation in China for treatment of relapsed/refractory multiple myeloma gsk.com ↗ |
| 2024-07-19 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the European Medicines Agency gsk.com ↗
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation. |
| 2024-06-02 | GlaxoSmithKline | Results Blenrep combination reduced the risk of disease progression or death by nearly 50% versus standard of care combination in relapsed/refractory multiple myeloma gsk.com ↗
On the primary endpoint of progression-free survival (PFS), a statistically significant and clinically meaningful improvement (hazard ratio [HR]: 0.52 [95% confidence interval (CI): 0.37-0.73], p-value<0.001) was observed with the belantamab mafodotin combination (n=155) compared to the bortezomib combination (n=147). |
| 2024-03-07 | GlaxoSmithKline | Results GSK announces positive results from DREAMM-8 phase III trial for Blenrep versus standard of care combination in relapsed/refractory multiple myeloma gsk.com ↗
The trial met its primary endpoint of progression-free survival (PFS) at a pre-specified interim analysis and was unblinded early based on the recommendation by an Independent Data Monitoring Committee (IDMC). |
| 2024-02-05 | GlaxoSmithKline | Results DREAMM-7 phase III trial shows Blenrep combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma gsk.com ↗
With a median follow-up of 28.2 months, the median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with the belantamab mafodotin combination compared to 13.4 months (11.1-17.5) in the daratumumab combination. |
| 2023-11-27 | GlaxoSmithKline | Results GSK announces positive results from DREAMM-7 head-to-head phase III trial for Blenrep in relapsed/refractory multiple myeloma gsk.com ↗
The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma. |
| 2022-11-22 | GlaxoSmithKline | Regulatory GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US Food and Drug Administration (FDA). |
| 2022-11-07 | GlaxoSmithKline | Results GSK provides update on DREAMM-3 phase III trial for Blenrep in relapsed/refractory multiple myeloma gsk.com ↗
The observed median progression-free survival was longer for belantamab mafodotin vs PomDex (11.2 months vs 7 months). |
| 2021-12-13 | GlaxoSmithKline | Results New data presented at ASH 2021 highlight potential of Blenrep (belantamab mafodotin-blmf) in combination with standard of care therapies in earlier lines of multiple myeloma treatment gsk.com ↗
Across all dosing cohorts (n=54), belantamab mafodotin plus PomDex resulted in an ORR of 88.9%, with 72.2% achieving a VGPR or better and a median progression-free survival (mPFS) of 17 months (95% CI, 14.5-not yet reached). |
| 2020-08-26 | GlaxoSmithKline | Regulatory European Commission approves BLENREP (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma gsk.com ↗
GlaxoSmithKline plc today announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. |
| 2020-08-06 | GlaxoSmithKline | Regulatory FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma gsk.com ↗ |
| 2020-07-24 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion recommending approval of belantamab mafodotin for the treatment of relapsed and refractory multiple myeloma gsk.com ↗
Today’s positive opinion from the CHMP is an important step in helping patients suffering from relapsed or refractory multiple myeloma who currently have limited options and poor outcomes. |
| 2020-07-14 | GlaxoSmithKline | Regulatory GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma gsk.com ↗ |
| 2020-06-19 | GlaxoSmithKline | Regulatory GSK announces FDA Advisory Committee meeting to review belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma gsk.com ↗
The ODAC will meet virtually on 14 July 2020. |
| 2020-05-27 | GlaxoSmithKline | Results DREAMM-2 and DREAMM-6 data at ASCO reinforce the potential of GSK’s investigational belantamab mafodotin in patients with relapsed/refractory multiple myeloma gsk.com ↗
GlaxoSmithKline (GSK) plc today announced new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical programme, which further highlight the potential of the investigational anti-BCMA (antibody drug conjugate against B-cell maturation antigen) agent belantamab mafodotin for relapsed/refractory multiple myeloma both as a monotherapy and in combination. |
| 2020-02-03 | GlaxoSmithKline | Regulatory GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma gsk.com ↗
GlaxoSmithKline plc today announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. |
| 2020-01-21 | GlaxoSmithKline | Regulatory US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma gsk.com ↗ |
| 2019-12-16 | GlaxoSmithKline | Results Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma gsk.com ↗
GlaxoSmithKline today announced treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31% overall response rate (ORR) with the 2.5 mg/kg regimen in patients with heavily pre-treated multiple myeloma. |
| 2019-08-23 | GlaxoSmithKline | Results GSK announces positive headline results from the pivotal DREAMM-2 study for multiple myeloma gsk.com ↗
The two-arm study met its primary objective and demonstrated a clinically meaningful overall response rate with belantamab mafodotin in the patient population. |
| 2019-03-21 | GlaxoSmithKline | Results GSK announces further positive data from DREAMM-1 study of anti-BCMA antibody-drug conjugate in patients with relapsed/refractory multiple myeloma gsk.com ↗
These new data confirm that 60% of patients receiving GSK2857916 achieved an overall response rate (ORR). |
| 2017-12-11 | GlaxoSmithKline | Results GSK presents promising new data for priority BCMA asset from its emerging Oncology pipeline at 59th ASH meeting gsk.com ↗
In this study of heavily pre-treated multiple myeloma patients (n=35), GSK2857916 monotherapy demonstrated a 60% response rate (95% confidence interval [CI]: 42.1% – 76.1%) and a median progression free survival of 7.9 months (95% CI: 3.1 – not estimable). |
| 2017-11-02 | GlaxoSmithKline | Regulatory GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma gsk.com ↗ |
All press releases naming this drug 39 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Belantamab mafodotin | “The two-part ALGONQUIN trial evaluated various doses and schedules of the anti-BCMA antibody-drug conjugate belantamab mafodotin plus pomalidomide and dexamethasone for...” PMID 38177852 ↗ Jan 202470“An Open-Label Phase Ib, Multicenter Study To Evaluate The Safety And Efficacy Of Belantamab Mafodotin Plus Cevostamab And Pomalidomide In Participants With Relapsed/Refractory...” NCT07831122 ↗ “Belantamab mafodotin was approved by the U.S. Food and Drug Administration (FDA) on Aug 5, 2020, for treating patients with relapsed/refractory multiple myeloma.” NCT04896658 ↗ “A Multicenter Study of Belantamab Mafodotin and Mezigdomide in Patients With Relapsed Multiple Myeloma” NCT07612787 ↗ “Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W” NCT05060627 ↗ “Biological: Belantamab Mafodotin” NCT04876248 ↗ |
| Known as | belamaf | “The phase 1/2 BelaRd (belantamab mafodotin [belamaf], lenalidomide, and dexamethasone) study evaluated the efficacy and safety of belamaf combined with lenalidomide and...” PMID 41346230 ↗ Apr 20266“Belantamab mafodotin (belamaf) combined with standard therapies demonstrated significant progression-free survival (PFS) and overall survival benefits in DREAMM-7 and PFS...” PMID 40763276 ↗ Nov 2025 “Belantamab mafodotin (belamaf), an antibody-drug conjugate targeting B-cell maturation antigen, has demonstrated single-agent activity in relapsed/refractory multiple myeloma...” PMID 41719502 ↗ May 2026 “Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class antibody-drug conjugate (ADC; or immunoconjugate) that delivers a cytotoxic payload, monomethyl auristatin F...” PMID 32712806 ↗ Jul 2020 “Belantamab mafodotin (belamaf) is a BCMA-targeted antibody-drug conjugate recently approved as monotherapy for adults with relapsed/refractory multiple myeloma who have...” PMID 33682447 ↗ Mar 2021 “Belantamab mafodotin (belamaf) has shown promising antimyeloma activity in relapsed or refractory multiple myeloma (RRMM) as a single agent.” PMID 38630908 ↗ Apr 2024 “belantamab mafodotin (belamaf)” NCT07831122 ↗ |
| Known as | Belantamab mafodotin blmf | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298209 ↗ |
| Known as | Belantamab mafodotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298209 ↗ |
| Known as | Belantamab mafodotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298209 ↗ |
| Known as | BLENREP | “belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT).” NCT05065047 ↗1“Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval.” NCT05874193 ↗ |
| Known as | GSK2857916 | “Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate...” NCT03828292 ↗10“Belantamab mafodotin (GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent activity in the phase 1 DREAMM-1 study in heavily pre-treated...” PMID 31859245 ↗ Dec 2019 “Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) comprised of an afucosylated, humanized Immunoglobulin G1 (IgG1) monoclonal immunoconjugate that binds...” NCT03763370 ↗ “Belantamab Mafodotin (GSK2857916) in Combination With Iberdomide (CC-220)/Dexamethasone Versus Belantamab Mafodotin (GSK2857916)/Dexamethasone in Relapsed Refractory Multiple Myeloma” NCT06232044 ↗ “Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)” NCT04549363 ↗ “belantamab mafodotin (GSK2857916), an antibody-drug conjugate targeting B-cell maturation antigen (BCMA)” NCT04680468 ↗ “the Antibody Drug Conjugate GSK2857916 in Chinese Participants” NCT04177823 ↗ “Belantamab Mafodotin (GSK2857916) as Monotherapy” NCT04126200 ↗ “Belantamab Mafodotin (GSK2857916)” NCT05064358 ↗ |
| Action | Deplete | “Belamaf binds to BCMA and eliminates myeloma cells by multimodal mechanisms of action.” PMID 33682447 ↗ Mar 2021 |
| Modality | Monoclonal antibody | “a novel afucosylated anti-BCMA monoclonal antibody conjugated with monomethyl auristatin F via noncleavable linker (GSK2857916)” PMID 26370838 ↗ Sep 2015 |
| Route | Intravenous | “Participants will receive GSK2857916 intravenously over 60 minutes” NCT02064387 ↗ |
| Target | TNFRSF17 | “Tumor necrosis factor receptor superfamily member 17 binding agent” CHEMBL4298209 ↗ |