Bristol Myers Squibb’s (BMS) Reblozyl (luspatercept) has been approved by the European Commission (EC) as a first-line treatment for transfusion-dependent anaemia in adults with lower-risk myelodysplastic syndromes (MDS).
Approximately 22 to 45 per 100,000 people aged over 70 years are affected by MDS, a group of closely related blood cancers characterised by the ineffective production of blood cells, which can lead to anaemia and frequent or severe infections.
MDS patients who develop anaemia often require blood transfusions. However, frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections.
Reblozyl, which is already approved in the EU to treat anaemia in adults with transfusion-dependent and non-transfusion-dependent beta-thalassaemia, is designed to promote the expansion and maturation of late-stage red blood cells.
Monica Shaw, senior vice president and head of European Markets at BMS, said: “With this approval for Reblozyl… more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to [the] current options available.”
The EC’s latest decision on the therapy is supported by positive results from the late-stage COMMANDS study, in which Reblozyl demonstrated superior efficacy compared to the erythropoiesis-stimulating agent epoetin alfa in the primary endpoint of concurrent red blood cell transfusion independence and haemoglobin increase.
Safety results were also consistent with previous MDS studies and in line with expected symptoms in this patient population, according to BMS.
Matteo Giovanni Della Porta, study investigator, Humanitas Cancer Center, said: “In the treatment of lower-risk MDS, few patients experience a lasting response to erythroid- stimulating agents, leaving a critical need for more effective treatment options to address the burden of their anaemia.
“Results from the COMMANDS study underscore the clinical value of Reblozyl as an initial treatment for anaemia in patients with low- to intermediate-risk MDS, and this approval represents a significant milestone towards improving treatment practice and offering better outcomes for patients.”
Reblozyl is being developed and commercialised through a global collaboration and North-American co-promotion agreement with Merck & Co – known as MSD outside the US and Canada – following Merck’s acquisition of Acceleron Pharma in November 2021.
The therapy is also approved in the US and Japan for the first-line treatment of anaemia in certain MDS patients.