The European Union has approved GSK’s (GSK.L), opens new tab drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood plasma cells, the British drugmaker said on Thursday.
EU regulators approved Blenrep after phase III trials showed the drug, when used in combination with standard treatments, extended progression-free survival and improved overall survival in patients with relapsed or refractory multiple myeloma, GSK said.
The approval comes a day after the U.S. Food and Drug Administration extended its review of the drug as a combination treatment for the same illness.
The FDA’s panel of independent experts had last week recommended against the drug, citing concerns about previously documented risks of eye-related side effects.
The EU approval marks the sixth regulatory nod for Blenrep combinations, with applications still under review across all major markets.
The drug delivers a cell-killing agent directly to tumour cells while limiting damage to healthy tissue — unlike conventional chemotherapy.
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. It affects the immunity-boosting plasma white blood cells.
