FDA Approves Bristol Myers Squibb Anemia Treatment

Bristol Myers Squibb announced FDA approval of Reblozyl (luspatercept-aamt) as a first-line treatment for anemia without previous erythropoiesis stimulating agent use (ESA-naïve) on Aug. 28, 2023. The drug is indicated for adult patients with low-to-intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

According to a company press release, FDA approval was based on interim results from the Phase III COMMANDS trial. In the trial, 58.6% of patients treated with luspatercept-aamt achieved the primary endpoints of concurrent RBC transfusion independence of at least 12 weeks and mean hemoglobin increase of at least 1.5 grams per deciliter within the first 24 weeks. This was deemed to be superior efficacy to epoetin alfa, an ESA which had a 31.2% efficacy rate, regardless of ring sideroblast status.

“Today's expanded approval of [luspatercept-aamt] 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,” said Wendy Short-Bartie, senior vice-president and general manager, U.S. Hematology and Cell Therapy, Bristol Myers Squibb, in the release. “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.”

“The majority of patients with MDS experience chronic anemia and require RBC transfusions,” said Tracey Iraca, executive director, MDS Foundation, in the release. “The approval of [luspatercept-aamt] in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.”

Source: Bristol Myers Squibb