FDA approves Reblozyl for certain adults with anemia and myelodysplastic syndrome
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The FDA approved luspatercept-aamt as first-line treatment for anemia among certain adults with myelodysplastic syndrome.
The indication applies to use of the agent by adults with very low- to intermediate-risk myelodysplastic syndrome (MDS) who have not received prior erythropoiesis-stimulating agents and may require regular red blood cell transfusions.
Luspatercept-aamt (Reblozyl, Bristol Myers Squibb) is an erythroid maturation agent.
The FDA previously approved the agent for treatment of anemia in multiple other specific patient populations.
The agency based the new first-line indication on interim results of the randomized phase 3 COMMANDS trial, which compared the efficacy and safety of luspatercept-aamt vs. epoetin alfa for treatment of anemia due to very low-, low- or intermediate-risk MDS among patients who are red blood cell transfusion dependent and were erythropoiesis-stimulating agent-naive.
As Healio previously reported, the study met its primary endpoint, showing a higher percentage of patients assigned luspatercept-aamt maintained red blood cell transfusion independence for 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL (58.5% vs. 31.2%; P <0.0001).
The most common adverse events reported with luspatercept-aamt included diarrhea, fatigue, hypertension, peripheral edema, nausea and dyspnea.
“For patients with lower-risk MDS, current standard therapies — including erythropoiesis-stimulating agents — have provided limited benefit in controlling anemia, with only one in three patients responding for a duration of 6 to 18 months,” Guillermo Garcia-Manero, MD, lead investigator of the COMMANDS trial and chief of the section of myelodysplastic syndrome at The University of Texas MD Anderson Cancer Center, said in a Bristol Myers Squibb-issued press release. “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 [with] epoetin alfa. [This] approval represents an important advancement for patients with lower-risk MDS.”
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