CHMP Issues Positive Opinion for Luspatercept in Anemia Due to MDS

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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, noted that initial analyses from the trial had been presented at previous meetings before discussing the results of the final analysis.

“In general, luspatercept is superior to an ESA as a frontline drug for patients with low-risk myelodysplastic syndromes,” Dr. Garcia Manero summarized.