# GSK Plc receives Japan approval for Blenrep combinations in multiple myeloma - Link: https://www.directorstalkinterviews.com/gsk-plc-receives-japan-approval-for-blenrep-combinations-in-multiple-myeloma/4121197204 - Published: 2025-05-19T08:03:25+01:00 - Author: Amilia Stone **[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**( LON/NYSE: GSK) has announced the approval of _Blenrep_ combinations by Japanfs Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with relapsed or refractory multiple myeloma. The approval is based on positive results from the DREAMM-7 and DREAMM-8 phase III trials evaluating _Blenrep_ in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone( BPd), respectively, in patients with multiple myeloma who have received at least one prior therapy. The approval follows an orphan drug designation for _Blenrep_ in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma. Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHLW approval of _Blenrep_ combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for _Blenrep_ combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.^(2,3,[4]) The safety and tolerability profiles of the _Blenrep_ combinations were broadly consistent with the known profiles of the individual agents.^(2,3)  > **Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said:** > Today’s approval brings the benefits of _Blenrep_ combinations to patients with > relapsed or refractory multiple myeloma in Japan. Patients need additional treatment > options at or after first relapse that can extend remission and survival versus > standard of care. _Blenrep_ combinations have the potential to redefine treatment > outcomes based on superior efficacy shown in two phase III trials, with the added > advantage of in-office administration in both academic and community treatment > settings. Most patients with multiple myeloma experience relapse, and in Japan only about 43% remain alive five years after diagnosis.^([5]) _Blenrep_ is the only anti-BCMA( B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients at or after relapse with a differentiated mechanism of action. _Blenrep_ combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation. In the DREAMM-7 and DREAMM-8 clinical trials, _Blenrep_ combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.^(2)^(,)^(3) Eye-related side effects associated with _Blenrep_ were successfully managed by extending time between infusions and through dose reductions, allowing patients to maintain benefit and resulting in low rates of discontinuation (≤9%) in both trials.^(2,3) Eye exam findings and changes in visual clarity (known as visual acuity) resolved in 83% of occurrences; with the trials ongoing, the remaining occurrences were in patients with follow-up ongoing or lost to follow-up. There have been no confirmed cases of permanent bilateral vision loss (i.e., no permanent bilateral eye exam findings of 20/200 or worse) based on current _Blenrep_ clinical trial data and previous monotherapy post-marketing use.^([6]) The most commonly reported non-ocular adverse events (>30% of participants) in the _Blenrep_ combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the _Blenrep_ combination arm of DREAMM- 8. This is the second major regulatory approval for _Blenrep_ combinations for the treatment of relapsed or refractory multiple myeloma, following the first authorisation in the world last month by the UK Medicines and Healthcare products Regulatory Agency( MHRA). _Blenrep_ combinations are currently under review in all major markets globally, including in the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025,^([7]) European Union,^([8]) China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application),^([9]) Canada, and Switzerland (with priority review for DREAMM-8). [1] Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20). doi:10.1182/blood-2014-11-568923. [2] Hungria V, Robak P, Hus M et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933. [3] Dimopoulos MA, Beksac M, Pour L, Delimpasi S et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. PMID: 38828951. [4] Hungria V, Robak P, H Marek et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. December 2024. [5] National Cancer Registry (Ministry of Health, Labour and Welfare), tabulated by Cancer Information Service, National Cancer Center, Japan. Available here: https:// ganjoho.jp/reg_stat/statistics/data/dl/en.html. Accessed 12 September 2024. [6] GSK data on file. [7] GSK press release issued 25 November 2024. Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations- accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple- myeloma/. [8] GSK press release issued 19 July 2024. Blenrep (belantamab mafodotin) combinations in multiple myeloma accepted for review by the European Medicines Agency. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin- combinations-in-multiple-myeloma-application-accepted-for-review-by-the-european- medicines-agency/. [9] GSK press release issued 9 December 2024. Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin- combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple- myeloma/. Share on: