The European Union has granted approval for GSK’s drug Blenrep to treat relapsed or treatment-resistant multiple myeloma, a cancer that affects plasma cells in the blood, the British pharmaceutical company announced on Thursday.
The green light from EU regulators follows positive results from phase III clinical trials, which demonstrated that Blenrep, when used in combination with standard therapies, significantly extended progression-free survival and improved overall survival in patients with relapsed or refractory multiple myeloma, according to GSK.
The approval adds to the growing momentum for Blenrep, marking its sixth regulatory authorization for use in combination therapies. However, regulatory reviews are still ongoing in several major markets.
The announcement comes just one day after the U.S. FDA extended its review of Blenrep for the same indication. Notably, an independent FDA advisory panel recently raised concerns about eye-related side effects seen in earlier studies and recommended against the drug's approval in the U.S. at this time.
Blenrep is designed to deliver a cell-killing agent directly to cancerous cells while minimizing damage to healthy tissue, offering a more targeted alternative to traditional chemotherapy.
Multiple myeloma is the third most common blood cancer worldwide. While it is generally manageable with treatment, it remains incurable and primarily affects plasma white blood cells, which are crucial for immune function.