GSK's BCMA ADC Blenrep (Belantamab Mafodotin) Gains FDA Approval in Combination Therapy, Marking Successful U.S. Market Re-Entry

Today, GSK announced that the U.S. FDA has approved its BCMA ADC drug Blenrep (belantamab mafodotin) for marketing, in combination with bortezomib and dexamethasone (BVd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies.

Notably, Blenrep was previously granted accelerated approval by the FDA in 2020 for use as a monotherapy in the later-line treatment of r/r MM patients, becoming the first approved BCMA ADC drug to reach the market.

However, in the subsequent definitive Phase 3 clinical DREAMM-3 trial (Blenrep monotherapy VS pomalidomide + dexamethasone), the clinical trial failed, and GSK initiated the withdrawal procedure of the drug in the United States in November 2022.

This approval means that Blenrep has successfully "revived" and regained eligibility to re-enter the U.S. market.

Image Source: YAOZHI Data - Global Drug Analysis System

Blenrep is an ADC targeting B-cell maturation antigen (BCMA). The antibody utilizes BioWa's POTELLIGENT technology from Kyowa Kirin's subsidiary, enhancing ADCC activity through defucosylation. For the ADC construct, a non-cleavable linker conjugates auristatin F toxin, with the linker licensed from Seagen.

The FDA's approval was based on data from the pivotal Phase 3 clinical trial DREAMM-7.

Analysis shows that in patients who have previously received at least two lines of therapy (including a proteasome inhibitor and an immunomodulatory agent), compared with the daratumumab-based triplet regimen (DVd), the Blenrep combination therapy reduced the risk of death by 51% (HR=0.49, 95%CI: 0.32–0.76) and extended the median progression-free survival (PFS) to three times longer, reaching 31.3 months, compared to 10.4 months in the DVd group.

The safety and tolerability profile of Blenrep combination therapy are generally consistent with the known profiles of each individual drug.

Previously, in July 2025, Blenrep received approval from the European Union (EU) in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; or in combination with pomalidomide and dexamethasone (BPd) for adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, including treatment containing lenalidomide.

In China, GSK submitted the marketing application for Blenrep (Belantamab Mafodotin) by the end of 2024, which was included in the priority review and breakthrough therapy designation by the CDE. The indication is for use in combination with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy.

In addition, GSK is striving to move Blenrep to earlier treatment lines.

Follow-up on overall survival (OS) for DREAMM-7 and DREAMM-8 is ongoing, with data expected to be released in early 2028, including patients who have received only one prior line of therapy.

GSK also launched a Phase 3 clinical study, DREAMM-10, in November 2024 for newly diagnosed MM patients. The study aims to compare the progression-free survival (PFS) and minimal residual disease (MRD) negativity rate of Blenrep + lenalidomide + dexamethasone versus daratumumab + lenalidomide + dexamethasone in newly diagnosed multiple myeloma (MM) patients who are not eligible for autologous stem cell transplantation.

GSK once boasted at its investor meeting that the peak sales of Blenrep could reach 3 billion pounds.

Image Source: GSK Official Website

Source: Yaoke Data - Global Drug Analysis System, GSK public information

Editor: Liuli

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