GSK is seeking FDA approval for Blenrep (belantamab mafodotin) in combination with Takeda’s Velcade (bortezomib) plus dexamethasone, and with Bristol Myers Squibb’s Pomalyst (pomalidomide) plus dexamethasone, marking a potential return to the multiple myeloma treatment landscape after its withdrawal in 2022. The FDA has accepted the biologics license application (BLA) with a PDUFA action date of July 23, 2025.
The application targets patients with multiple myeloma who have received at least one prior line of therapy. This follows Blenrep's initial FDA approval in August 2020 as a monotherapy for relapsed or refractory multiple myeloma, which was later withdrawn due to failing to demonstrate superiority over Pomalyst plus dexamethasone in a Phase III confirmatory study.
Clinical Trial Data and Efficacy
The current application is supported by data from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) Phase III 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 other 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
Blenrep, an anti-B cell maturation antigen (BCMA) therapy, is expected to introduce new competition for J&J and Legend Biotech’s BCMA CAR-T Carvykti (ciltacabtagene autoleucel) and potentially for BCMA-targeted T cell engagers such as Johnson & Johnson’s (J&J’s) Tecvayli (teclistamab). GlobalData consensus forecasts project Blenrep to generate $1.4 billion in 2030, while Carvykti is expected to make $5.9 billion and Tecvayli $6.4 billion in the same year.
Advantages of Blenrep Combination
The Blenrep combo treatment could offer advantages compared to CAR-T therapy, due to its off-the-shelf nature and a simpler administration of intravenous (IV) infusion without the need for premedication, step-up dosing, or hospitalization.
Multiple Myeloma Disease Burden
According to a GlobalData report, there will be 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
In the announcement accompanying the BLA, Hesham Abdullah, senior vice president and global head of oncology R&D at GSK said: “Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration.”
