Drugs / Belantamab
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 4 milestones | |||||
| Filed | EU (EMA) | — | plasma cell myeloma | 2020-06-04 | “Biologics License Application (BLA) and Marketing Authorisation Application (MAA), are currently under review by the US Food and Drug Administration and European Medicines...” gsk.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | 2020-06-04 | “Biologics License Application (BLA) and Marketing Authorisation Application (MAA), are currently under review by the US Food and Drug Administration and European Medicines...” gsk.com ↗ |
| Filed | EU (EMA) | — | plasma cell myeloma | 2020-02-03 | “European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for belantamab mafodotin” gsk.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | 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 relapsed/refractory diffuse large B-cell lymphoma 6 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 | US (FDA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | 2024-11-25 | “the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep” gsk.com ↗ |
| Filed | Japan (PMDA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | 2024-09-17 | “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)” gsk.com ↗ “Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple myeloma accepted for regulatory review in Japan.” gsk.com ↗ |
| Filed | EU (EMA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | 2024-07-19 | “today announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin)” gsk.com ↗ “Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the European Medicines Agency.” gsk.com ↗ |
| Filed | Other | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | — | “belantamab mafodotin combinations have been filed in the US, European Union1, Japan2, United Kingdom, Canada and Switzerland” gsk.com ↗ |
| Filed | UK (MHRA) | Blenrep | relapsed/refractory diffuse large B-cell lymphoma | — | “belantamab mafodotin combinations have been filed in the US, European Union1, Japan2, United Kingdom, Canada and Switzerland” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06413511 | Jun 2024 → Jul 2025 | autoimmune disease | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 33
| 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 ↗
New Blenrep (belantamab mafodotin) results will highlight potential for long-term efficacy in relapsed or refractory multiple myeloma and meaningful activity in newly diagnosed patients |
| 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 ↗
The approval is based on superior efficacy results demonstrated by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. |
| 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 ↗
GSK plc (LSE/NYSE: GSK) notes that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations. |
| 2025-05-23 | GlaxoSmithKline | Regulatory Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Blenrep |
| 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 ↗
Today’s regulatory filing acceptance, with a priority review, is a meaningful step forward in our efforts to bring the benefits of Blenrep in combination to patients in China. |
| 2024-11-25 | GlaxoSmithKline | Regulatory Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma gsk.com ↗ |
| 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 belantamab mafodotin combination significantly extended the time to disease progression or death versus the standard of care combination. |
| 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 ↗
Blenrep (belantamab mafodotin) plus BorDex showed statistically significant progression-free survival (PFS) benefit versus daratumumab plus BorDex |
| 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 ↗
GSK plc (LSE/NYSE: GSK) today announced that DREAMM-3, the phase III open-label, randomised head-to-head superiority trial of Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma (RRMM), did not meet its primary endpoint of progression-free survival (PFS). |
| 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 ↗
BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved in the European Union |
| 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 ↗
The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union. |
| 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 ↗
Initial results from the DREAMM-6 study show belantamab mafodotin in combination with bortezomib and dexamethasone results in a 78% overall response rate |
| 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 ↗
Issued: London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916). |
All press releases naming this drug 35 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Belantamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06413511 ↗ |
| Known as | GSK2857914 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298208 ↗ |
| Modality | Monoclonal antibody | — CHEMBL4298208 ↗ |
| Route | Intravenous | “Single Intravenous Infusion of Belantamab” NCT06413511 ↗ |