Bristol Myers Squibb gets USFDA nod for Reblozyl as first line treatment of Anemia in lower risk MDS

In the Phase 3 COMMANDS trial, results showed 58.5% (n=86) of patients treated with Reblozyl vs. 31.2% (n=48) of patients treated with epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with a mean Hb increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001). 

“The 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,” said Wendy Short-Bartie, senior vice president and general manager, U.S. Hematology and Cell Therapy, Bristol Myers Squibb. “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. “The approval of Reblozyl 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.”

Results from the COMMANDS study were featured in June as part of the press program at the American Society of Clinical Oncology (ASCO) Annual Meeting and plenary session at the European Hematology Association (EHA) Congress, with simultaneous publication in The Lancet. Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021.