GSK cements Blenrep comeback with MHRA approval
GSK's Blenrep (belantamab mafodotin) has officially been approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), its first approval in the world for the multiple myeloma drug - at least the first approval this go-round.
Blenrep won accelerated approval in 2020 as a fourth-line or later treatment for multiple myeloma, but it was withdrawn from sale following the failure 2020's DREAMM-3 study to show an improvement in progression-free survival (PFS) or overall survival (OS) when used as a third-line or later treatment.
But that wasn't the end of the story for the antibody-drug conjugate. At last year's ASCO, the company presented data from the DREAMM-8 study that promised to put the drug back on track. That study saw a progress-free survival (PFS) of 71% for the Blenrep group after a year on the treatment, compared to 51% with the standard of care, a 48% improvement. Combined with additional positive data from the DREAMM-7 study, it was enough for the company to begin another round of regulatory approvals, this time as a second round treatment.
Late last year, additional survival data from DREAMM-7 further boosted the company's confidence.
“Today's approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse," Hesham Abdullah, SVP and global head of oncology R&D at GSK, said in a statement. "As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.”
Specifically, it is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.
As the only the only anti-BCMA (B-cell maturation antigen) ADC in multiple myeloma, GSK hopes the drug will present an attractive alternative to cell therapies like Johnson & Johnson's Carvykti (ciltacabtagene autoleucel) and Bristol-Myers Squibb's Abecma (idecabtagene vicleucel), both of which require expensive and elaborate infrastructure that characterises CAR-T therapies.
GSK is seeking approval in 14 additional countries, including the United States, where it has a PDUFA date of 23rd July. The drug was originally hoped to be a blockbuster for the company, with initial projections of $3 billion in revenue or more.
