GSK is seeking FDA approval for Blenrep (belantamab mafodotin) in combination with other therapies for the treatment of multiple myeloma. The FDA has accepted the biologics license application (BLA) for Blenrep in combination with Takeda’s Velcade (bortezomib) plus dexamethasone, and Bristol Myers Squibb’s Pomalyst (pomalidomide) plus dexamethasone, for 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 July 23, 2025. This marks a potential return to the market for Blenrep, which was voluntarily withdrawn in 2022.
Background on Blenrep
Blenrep, an anti-B cell maturation antigen (BCMA) therapy, was initially granted accelerated approval by the FDA in August 2020 as a monotherapy for relapsed or refractory multiple myeloma. However, GSK withdrew the drug after a Phase III confirmatory study failed to demonstrate superiority over the combination of Pomalyst plus dexamethasone. The European Medicines Agency (EMA) also did not renew its conditional marketing authorization in 2023.
Clinical Trial Data
The current application is supported by data from the Phase III DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) trials. Both trials met their primary endpoints, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the Blenrep combinations compared to standard-of-care triplet combinations. The studies also showed clinically meaningful improvements across all secondary efficacy endpoints. The safety and tolerability profiles of the Blenrep combinations were consistent with the known profiles of the individual agents.
Market Impact and Competition
If approved, the Blenrep combination treatment could provide a new option for patients with multiple myeloma. It is expected to compete with existing BCMA-targeted therapies such as Johnson & Johnson and Legend Biotech’s BCMA CAR-T Carvykti (ciltacabtagene autoleucel) and J&J’s Tecvayli (teclistamab). While analysts forecast Blenrep to generate $1.4 billion in 2030, Carvykti and Tecvayli are projected to generate $5.9 billion and $6.4 billion, respectively, in the same period.
One potential advantage of the Blenrep combination is its off-the-shelf nature and simpler administration via intravenous (IV) infusion, without the need for premedication, step-up dosing, or hospitalization required for CAR-T therapies.
Disease Burden
According to GlobalData, there will be an estimated 305,020 diagnosed prevalent cases of multiple myeloma in the eight major markets (the US, France, Germany, Italy, Spain, the UK, Japan, and China) by 2032.
Expert Commentary
Hesham Abdullah, senior vice president and global head of oncology R&D at GSK, stated that the approval of Blenrep could transform the treatment landscape for relapsed/refractory multiple myeloma by providing additional, efficacious treatment options with manageable side effects and community-based administration.
