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     125  0 Kommentare Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

    Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Upon approval, this would represent the fourth authorized indication for Reblozyl in the EU.

    The CHMP adopted a positive opinion based on results from the pivotal Phase 3 COMMANDS trial. Results from the primary analysis showed 60.4% (n=110) of patients treated with Reblozyl vs. 34.8% (n=63) of patients treated with epoetin alfa achieved the primary endpoint of red blood cell (RBC) transfusion independence of at least 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001). Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.

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    “The positive recommendation by CHMP for Reblozyl can provide an important first-line treatment option for patients with lower-risk MDS in Europe,” said Anne Kerber, M.D., senior vice president, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “Current treatments, including erythropoiesis stimulating agents, provide limited benefit against anemia. Results from the head-to-head COMMANDS study show that Reblozyl delivered transfusion independence in nearly twice the number of patients compared with epoetin alfa, and with a longer duration of response.”

    About COMMANDS

    COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve.

    The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks.

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    Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS) Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with …

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