FDA Approval Insights: First-Line Luspatercept for Anemia in Lower-Risk MDS

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Uwe Platzbecker, MD, about the FDA approval of luspatercept-aamt (Reblozyl) for patients with lower-risk myelodysplastic syndrome (MDS) with anemia. Dr Platzbecker is the director of the Clinic and Polyclinic for Hematology, Cell Therapy, and Hemostaseology at the University Hospital Leipzig in Germany.

On August 28, 2023, the FDA granted approval of luspatercept for anemia in patients with very low- to intermediate-risk MDS who have received no prior erythropoiesis-stimulating agents (ESAs) and who may require regular red blood cell (RBC) transfusions. This approval was backed by findings from the phase 3 COMMANDS trial (NCT03682536), in which luspatercept elicited RBC transfusion independence for at least 12 weeks in 59% of patients in the investigational arm. Conversely, the RBC transfusion independence rate was 31% in patients who received the ESA epoetin alfa (common risk difference on response rate, 26.6; 95% CI, 15.8-37.4; P < .0001).

In our exclusive interview, Dr Platzbecker discussed the significance of this approval; key efficacy and safety data from COMMANDS; and how this approval addresses historically unmet needs for patients with MDS.

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Editor’s Note: This interview was conducted prior to the FDA approval of luspatercept in patients with lower-risk MDS with anemia.