After its market withdrawal in 2022, GSK’s multiple myeloma drug Blenrep (belantamab mafodotin) is poised to re-enter the treatment landscape for multiple myeloma.
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 However, the drug was later withdrawn from the market after failing to demonstrate superiority over the combination of Pomalyst plus dexamethasone in a Phase III confirmatory study.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.
The 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). According to GlobalData consensus forecasts, Blenrep is set to generate $1.4bn in 2030. Other drugs are expected to pull in higher revenues, with Carvykti set to make $5.9bn and Tecvayli $6.4bn in the same year.
The Blenrep combo treatment could offer advantages compared to CAR-T therapy, due to the off-the-shelf nature and a simpler administration of intravenous (IV) infusion without the need for premedication, step-up dosing, or hospitalisation.
According to a report on GlobalData’s Pharmaceutical Intelligence Center, 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.
GlobalData is the parent company of Pharmaceutical Technology.
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.”
