Luspatercept Likely to Receive Fourth Indication in the EU for Anemia Due to MDS

The European Medicines Agency Committee for Medicinal Products for Human Use issued a positive opinion recommending that the European Commission (EC) approve luspatercept (Reblozyl^®) for the treatment of transfusion-dependent anemia due to myelodysplastic syndromes (MDS), according to a press release from Bristol Myers Squibb, the manufacturer of the drug.

If approved by the EC, adult patients with very low-, low-, and intermediate-risk MDS would be eligible to receive luspatercept to reduce transfusion requirements. This would be the fourth authorized indication for luspatercept in the European Union.

The phase III COMMANDS trial compared luspatercept with epoetin alfa, an erythropoiesis-stimulating agent, in patients with low-risk MDS dependent on transfusions. Principal Investigator Guillermo Garcia-Manero, MD, of the University of Texas MD Anderson Cancer Center, led a panel discussion on the final readout of the trial at the 65th American Society of Hematology Annual Meeting & Exposition in San Diego, California.