The European Commission (EC) has granted expanded approval for Bristol Myers Squibb's (BMS) Reblozyl (luspatercept) as a first-line treatment for adults with transfusion-dependent anaemia associated with very low, low and intermediate-risk myelodysplastic syndromes (MDS).
The decision is applicable in all the member states of the European Union (EU).
The EC’s expanded approval is based on the results from the open-label, randomised Phase III COMMANDS study.
The trial assessed the efficacy and safety of Reblozyl compared to epoetin alfa, an erythropoiesis-stimulating agent, in treating anaemia due to MDS.
It included subjects who needed red blood cell (RBC) transfusions and had not previously received erythropoiesis-stimulating agents.
Reblozyl significantly outperformed epoetin alfa in achieving concurrent RBC transfusion independence and a rise in haemoglobin levels - the study's primary endpoint.
Safety results were in line with previous studies on MDS, with no significant differences in progression to acute myeloid leukaemia or total deaths between the study arms.
This approval is the fourth indication authorised for Reblozyl in Europe, positioning it as a first-in-class treatment for people with disease-related anaemia and the first therapy to demonstrate superior efficacy versus epoetin alfa in lower-risk MDS (LR-MDS).
Reblozyl is a product of a global collaboration and is co-promoted in North America by Merck (MSD), following its acquisition of Acceleron Pharma in November 2021.
It has also been approved in the US and Japan for the first-line treatment of anaemia associated with LR-MDS.
Bristol Myers Squibb European Markets senior vice-president and head Monica Shaw stated: “With this approval for Reblozyl as a first-line treatment for anaemia in adults with LR MDS, more patients in the EU will have the potential to become transfusion independent for longer periods compared to current options available.
“This milestone underscores our ongoing commitment to developing new options for patients with disease-related anaemia.”
Last month, the EC approved BMS’ Abecma (idecabtagene vicleucel; ide-cel) to treat adults with relapsed and refractory multiple myeloma.
