FDA approves BMS’s Reblozyl for treatment of anaemia in adults with lower-risk MDS

Betsy Goodfellow | August 30, 2023 | News story | Research and Development FDA, Haematology, Reblozyl, anaemia, bristol myers squibb, myelodysplastic syndromes 

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the treatment of anaemia without precious erythropoiesis stimulating agent use (ESA-naïve) in adult patients with low- to intermediate-risk myelodysplastic syndromes (MDS) who may need regular red blood cell (RBC) transfusions.

The expanded indication to the first-line setting follows interim results from the pivotal phase 3 COMMANDS trial, throughout which the drug has demonstrated superior efficacy of concurrent RBC transfusion independence (RBC-TI) and haemoglobin (Hb) increase compared to epoetin alfa, an ESA, regardless of ring sideroblast status.

Guillermo Garcia-Manero, MD, lead investigator and chief of the Section of Myelodysplastic Syndromes at the University of Texas MD Anderson Cancer Center, US, commented: “For patients with lower-risk MDS, current standard therapies, including ESAs, have provided limited benefit in controlling anemia with only one in three patients responding for a duration of six to 18 months. Results from the COMMANDS study showed nearly twice as many patients treated with Reblozyl achieved transfusion independence of at least 12 weeks and concurrent hemoglobin increase compared to epoetin alfa. Today’s approval represents an important advancement for patients with lower-risk MDS.”

Wendy Short-Bartie, senior vice president and general manager, US Hematology and Cell Therapy at BMS, added: “Today’s expanded approval of Reblozyl marks an important milestone in our commitment to MDS patients with anemia by providing a durable and more effective treatment option, with more convenient and less frequent administration. We remain dedicated to addressing hard-to-treat diseases with significant burden to patients and look forward to bringing this important option earlier in the treatment process.”

Betsy Goodfellow

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