INDICATIONS

REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

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ESA FAILURE

Plan for what's next
Only 1 in 3 patients with MDS may respond to ESAs.1

Duration of response ranges from 6 to 18 months.1-3*

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) defines lack of response to ESAs as4:

<1.5 g/dL rise in hemoglobin by 6-8 weeks of treatment

OR

No decrease in RBC transfusion requirement by 6-8 weeks of treatment

NCCN=National Comprehensive Cancer Network (NCCN®).

Reblozyl® (luspatercept-aamt) package, vial, and syringe

When ESAs fail, REBLOZYL can provide meaningful benefit for your patients

ESA failure video thumbnail

Hear from an expert how lower-risk MDS patients may need an alternative treatment option after ESA failure

International Working Group (IWG) 2006 Criteria for Hi-E: Hgb increase by 1.5 g/dL for at least 8 weeks or reduction of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks

Fenaux Study Design: A phase 3, double-blind, placebo-controlled study to assess the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (ie, low risk) MDS patients (N=130) with Hgb≤10 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized 2:1 to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response by IWG 2006 criteria through Week 24.

Park Study Design: A multinational, retrospective, cohort study of patients (N=1698) with non-del(5) lower-risk MDS treated with ESAs. Primary ESA failure was defined as the absence of erythroid response according to IWG 2006 criteria after 8 weeks of ESA treatment. Secondary failures of ESA treatment were defined as relapse after an initial Hi-E. The potential effects of primary and secondary failure on subsequent outcomes were evaluated.

Platzbecker Study Design: A phase 3, randomized, double-blind, placebo-controlled study of darbepoetin alfa in ESA-naïve patients (N=147) with low- or intermediate-1 risk MDS and anemia. Patients were randomized 2:1 to receive darbepoetin alfa or placebo for 24 weeks followed by 48 weeks of open-label darbepoetin alfa for all patients and ongoing long-term follow-up. Endpoints included transfusion incidence and Hi-E by IWG 2006 criteria.

*Based on the clinical trial results from Fenaux, Park and Platzbecker.

ESA FAILURE

Plan for what's next
Only 1 in 3 patients with MDS may respond to ESAs.1

Duration of response ranges from 6 to 18 months.1-3*

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) defines lack of response to ESAs as4:

<1.5 g/dL rise in hemoglobin by 6-8 weeks of treatment

OR

No decrease in RBC transfusion requirement by 6-8 weeks of treatment

NCCN=National Comprehensive Cancer Network (NCCN®).

Reblozyl® (luspatercept-aamt) package, vial, and syringe

When ESAs fail, REBLOZYL can provide meaningful benefit for your patients

ESA failure video thumbnail

Hear from an expert how lower-risk MDS patients may need an alternative treatment option after ESA failure

International Working Group (IWG) 2006 Criteria for Hi-E: Hgb increase by 1.5 g/dL for at least 8 weeks or reduction of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks

Fenaux Study Design: A phase 3, double-blind, placebo-controlled study to assess the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (ie, low risk) MDS patients (N=130) with Hgb≤10 g/dL, with no or moderate RBC transfusion dependence (≤4 RBC units/8 weeks). Patients were randomized 2:1 to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response by IWG 2006 criteria through Week 24.

Park Study Design: A multinational, retrospective, cohort study of patients (N=1698) with non-del(5) lower-risk MDS treated with ESAs. Primary ESA failure was defined as the absence of erythroid response according to IWG 2006 criteria after 8 weeks of ESA treatment. Secondary failures of ESA treatment were defined as relapse after an initial Hi-E. The potential effects of primary and secondary failure on subsequent outcomes were evaluated.

Platzbecker Study Design: A phase 3, randomized, double-blind, placebo-controlled study of darbepoetin alfa in ESA-naïve patients (N=147) with low- or intermediate-1 risk MDS and anemia. Patients were randomized 2:1 to receive darbepoetin alfa or placebo for 24 weeks followed by 48 weeks of open-label darbepoetin alfa for all patients and ongoing long-term follow-up. Endpoints included transfusion incidence and Hi-E by IWG 2006 criteria.

*Based on the clinical trial results from Fenaux, Park and Platzbecker.

References: 1. Fenaux P, Santini V, Spiriti MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658. 2. Park S, Hamel J-F, Toma A, et al. Outcome of lower-risk patients with myelodysplastic syndromes without 5q deletion after failure of erythropoiesis-stimulating agents. J Clin Oncol. 2017;35(14):1591-1597. 3. Platzbecker U, Symeonidis A, Oliva EN, et al. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017;31(9):1944-1950. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed October 11, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

2007-US-2300019     04/2023