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First-in-class anaemia therapy granted expanded approval

The expanded authorisation of Reblozyl is based on a Phase III trial which showed that the treatment nearly doubled the percentage of certain transfusion-dependent anaemia patients achieving haemoglobin increase, compared to epoetin alfa.

Reblozyl anaemiaReblozyl anaemia

The European Commission (EC) has expanded the approval of Reblozyl ® (luspatercept) to include the first-line treatment of adults with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).

This indication expansion of Reblozyl covers all EU member states, excluding Great Britain. Bristol Myers Squibb stated that this makes it the fourth authorised indication in Europe for Reblozyl.

“With this approval for Reblozyl as a first-line treatment for anaemia in adults with lower-risk MDS, more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to current options available,” stated Dr Monica Shaw, Senior Vice President and Head of European Markets, Bristol Myers Squibb.

The approval is based on the pivotal Phase III COMMANDS clinical trial, in which Reblozyl demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent. Specifically, the study’s primary endpoint evaluated concurrent red blood cell transfusion independence and haemoglobin increase.

“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,” Dr Matteo Giovanni Della Porta, study investigator and Head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy shared.

Therefore, these 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,” he explained.

Reblozyl primary analysis data

Bristol Myers Squibb stated that findings from the intent to treat population demonstrated:

  • 60.4 percent of patients receiving Reblozyl versus 34.8 percent of patients receiving epoetin alfa achieved the primary endpoint of RBC transfusion independence of at least 12 weeks with concurrent mean Hb increase of at least 1.5 g/dL within the first 24 weeks
  • HI-E increase of at least eight weeks was achieved by 74.2 percent of Reblozyl patients compared to 53 percent of epoetin alfa patients
  • There were 68.1 percent of Reblozyl patients compared to 48.6 percent of epoetin alfa patients who achieved RBC transfusion independence for at least 12 weeks
  • Lastly, duration of response was 128.1 weeks in patients given Reblozyl who achieved transfusion independence for at least 12 weeks (achieved weeks 1-24). This was compared to 89.7 weeks for epoetin alfa.

Reblozyl is not indicated for use in US patients with non-transfusion-dependent beta thalassemia. However, it is also approved in the US and Japan for the first-line treatment of anaemia associated with lower-risk MDS, Bristol Myers Squibb confirmed.

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