Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2611 |
| INN | Belantamab mafodotin |
| Status | Regulatory review |
| Drug code(s) | GSK2857916, J6M0-mcMMAF |
| Brand name | BLENREP |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | mc, Non-cleavable linker |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin F (MMAF) |
| Discovery method/technology | None |
| Target(s) | BCMA |
| Indications of clinical studies | Multiple myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review EU, US, Japan, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2014 |
| Start of Phase 2 | |
| Start of Phase 3 | June 18, 2018 |
| Date BLA/NDA submitted to FDA | December 05, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | August 05, 2020 |
| INN, US product name | Belantamab mafodotin, belantamab mafodotin-blmf |
| US or EU approved indications | Approval in the US withdrawn: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. |
| Company | GlaxoSmithKline |
| Licensee/Partner | None |
| Comments about company or candidate | Nov 2024: The US Food and Drug Administration (FDA) has accepted a biologics license application (BLA) for Blenrep in combination with Takeda’s Velcade (bortezomib) plus the steroid dexamethasone, as well as Bristol Myers Squibb’s Pomalyst (pomalidomide) plus dexamethasone. The application seeks approval for the treatment of multiple myeloma patients who have received at least one prior line of therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 23 July 2025. Blenrep was originally approved by the FDA in August 2020 as a monotherapy for relapsed or refractory multiple myeloma. However, the drug was later withdrawn from the market after failing to demonstrate superiority over the combination of Pomalyst plus dexamethasone in a Phase III confirmatory study. The European Medicines Agency (EMA) followed suit by not renewing the conditional marketing authorisation for Blenrep in 2023. The current US application is based on results from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) Phase III trials. Both trials met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the Blenrep combinations compared to standard-of-care triplet combinations. Both studies also showed clinically meaningful improvements across all other secondary efficacy endpoints. The safety and tolerability profiles of the Blenrep combinations were consistent with the known profiles of the individual agents. Sep 2024: GSK plc 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. MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma. This is the third major regulatory filing acceptance for belantamab mafodotin combinations in the treatment of relapsed/refractory multiple myeloma, following marketing authorisation application acceptance by the European Medicines Agency (EMA) in July 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK earlier this month. July 19, 2024: GSK plc announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) 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. 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. Sep 2023: CHMP recommended not renewing the conditional marketing authorisation BlenRep (belantamab mafodotin) Nov 2022: GSK plc 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). This request was based on the previously announced outcome of the DREAMM-3phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations. On Aug 26, 2020, GlaxoSmithKline plc 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. BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care. On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. FDA granted orphan drug designation, breakthrough therapy designation, and priority review to belantamab mafodotin-blmf for this indication. GlaxoSmithKline announced the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The ODAC will meet virtually on July 14, 2020. Priority review granted. Dec 16, 2019: Submission of BLA announced. NCT04091126 Phase 1 in MM started in Dec 2019. August 23, 2019: GlaxoSmithKline plc announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916). Data from the DREAMM-2 study will be the basis for regulatory filings starting later this year. DREAMM-3 Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GSK’916 Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma planned. March 2019: Updated results from GlaxoSmithKline's Phase I clinical trial evaluating its candidate GSK2857916 for multiple myeloma showed a 60% overall response rate and a 15% complete response rate during the 12-month follow-up period, as reported in Blood Cancer Journal. NCT03848845 Phase 2 study started recruiting in March 2019. NCT03828292 Phase 1 study in Japanese Subjects With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments not yet recruiting as of Feb 5 2019. NCT03525678 Phase 2 (DREAMM 2) study in multiple myeloma started June 18 2018. Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for GSK2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent; PRIME designation for treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. Orphan designations in US and EU for multiple myeloma. NCT02064387 Phase 1 study recruiting patients as of June 10, 2015. mAb also known as J6M0-mcMMAF utilizes Seattle Genetics technology; humanized afucosylated mAb, uncleavable linker. Listed as Phase 1/2 in GSK press release dated July 26 2017 (https://www.gsk.com/media/3866/press-release-gsk-delivers-further-progress-in-q2-and-sets-out-new-priorities-for-the-group-26-july-2017.pdf). |
| Full address of company | 980 Great West Road Brentford Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
Afucosylated; ave. 4 drugs/Ab, non-cleavable mc linker. The drug linker technology is licensed from Seattle Genetics; the antibody is produced using POTELLIGENT Technology licensed from BioWa.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |