FDA expands Reblozyl approval to first-line use

Blood cells

The US Food and Drug Administration (FDA) has expanded the use of Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) to include first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

The approval is for the treatment of anaemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk MDS who may require regular red blood cell (RBC) transfusions.

It is the first therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anaemia according to interim results from pivotal Phase III COMMANDS trial.

In a head-to-head study, results showed Reblozyl nearly doubled the percent of patients achieving the primary endpoint of concurrent transfusion independence and haemoglobin (Hb) increase vs. epoetin alfa.

“For patients with lower-risk MDS, current standard therapies, including ESAs, have provided limited benefit in controlling anaemia, with only one in three patients responding for a duration of six to 18 months,” said Guillermo Garcia-Manero, lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center. “Today’s approval represents an important advancement for patients with lower-risk MDS.”

In the COMMANDS trial, results showed 58.5% of patients treated with Reblozyl vs. 31.2% of patients treated with epoetin alfa achieved the primary endpoint of RBC transfusion independence (RBC-TI) of at least 12 weeks with a mean Hb increase of at least 1.5 g/dL within the first 24 weeks.

“The majority of patients with MDS experience chronic anaemia and require RBC transfusions,” said Tracey Iraca, Executive Director, MDS Foundation. “The approval of Reblozyl in the first-line treatment of anaemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.”

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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