All articles tagged with #blenrep
GSK's blood cancer drug Blenrep received a narrower FDA approval than expected, leading to a more than 5% drop in GSK stock; despite showing some survival benefits in studies, concerns over ocular side effects and a panel's risk assessment limited its approval prospects.
The US FDA has approved GSK's Blenrep in combination with bortezomib and dexamethasone for treating relapsed/refractory multiple myeloma in patients who have received at least two prior therapies, based on positive results from the DREAMM-7 trial showing significant survival benefits. Blenrep is notable for its community accessibility and ongoing development in earlier treatment lines.
The FDA approved GSK's blood cancer drug Blenrep for use in one combination regimen but rejected another, marking a complex decision in the drug's regulatory history.
FDA advisers have voted that the risks of GSK's blood cancer drug Blenrep outweigh its benefits due to serious eye-related side effects and dosing concerns, potentially impacting its approval decision next week.
GSK has announced positive results from the DREAMM-7 phase III trial, showing that the combination of Blenrep (belantamab mafodotin) with bortezomib plus dexamethasone (BorDex) significantly extended progression-free survival (PFS) compared to the standard of care regimen of daratumumab plus BorDex in patients with relapsed or refractory multiple myeloma. The trial also showed a strong trend towards improved overall survival (OS). The safety profile of the combination was consistent with the known safety profile of the individual agents. Further data from the trial will be presented at a scientific meeting and shared with health authorities.