British pharmaceutical giant GlaxoSmithKline (GSK, Financial) announced that its blood cancer drug, Blenrep, significantly reduced the risk of death in cancer patients when used in combination with another therapy. This development enhances the prospects of reintroducing Blenrep, previously withdrawn by the FDA and European Medicines Agency, to the market.
GSK noted that combining Blenrep with a therapy known as BorDex extended the lives of patients with relapsed multiple myeloma. The company described the late-stage clinical trial results as potentially transformative for patients.
Earlier this year, GSK indicated that when Blenrep was combined with a treatment called PomDex, it helped slow disease progression. The latest trial results, recently disclosed, could persuade regulators of the drug's efficacy. Blenrep represents a crucial part of GSK's efforts in cancer treatment, following setbacks in 2022.
Previously, the FDA required the cancer drug to be withdrawn due to failures in clinical trials for multiple myeloma. The European Medicines Agency also advised against extending its conditional approval. GSK has now resubmitted applications for Blenrep in the United States, Europe, and Japan.
Blenrep, also known as Belantamab Mafodotin, is an antibody-drug conjugate for treating relapsed or refractory multiple myeloma. It was initially pulled from the market due to inadequate efficacy in key clinical trials and high corneal toxicity. However, with new combination therapy results, regulators might reconsider its approval, especially with enhanced safety monitoring.
GSK projected that if Blenrep receives regulatory approval, it could generate annual sales exceeding £3 billion (approximately $3.8 billion). However, it has been excluded from GSK's own performance outlook until such approval is granted.
