FDA Reblozyl Approval LR-MDS

Bristol Myers Squibb (BMS) announced on Monday August 28, 2023 that Reblozyl, a first-in-class erythroid maturation agent, has been approved to treat MDS related anemia in erythropoiesis stimulating agent naive (ESA-naive) patients with very low- to intermediate-risk MDS. 

This approval makes Reblozyl the first and only approved therapeutic agent that is more effective at treating MDS related anemia than ESA’s, which had previously been one of the best options MDS patients had to treat their anemia. 

Dr. Guillermo Garcia-Manero, lead COMMANDS study investigator and Chief of Myelodysplastic Syndromes at MD Anderson Cancer Center comments on the efficacy of Reblozyl:

“For patients with lower-risk MDS, current standard therapies, including ESAs, have provided limited benefit in controlling anemia with only 1 in 3 patients responding for a duration of 6-18 months. Results from the COMMANDS study showed nearly twice as many patients treated with Reblozyl achieved transfusion independence of at least 12 weeks and concurrent hemoglobin increase compared to epoetin alfa. Today’s approval represents an important advancement for patients with lower-risk MDS.”

This approval is an exciting moment for the MDS community, doctors, patients, and caregivers alike, who haven’t seen new and effective therapeutic options for treating anemia in far too long.

What is Reblozyl for LR-MDS?

Chronic anemia is a huge problem for the majority of MDS patients. The burden of living with anemia is no small thing. Many patients living with chronic anemia have been watching anxiously to see if Reblozyl would be an option for them to help improve not only how they feel, but also their overall quality of life. 

Erythropoiesis is the process by which our red blood cells are naturally produced. Reblozyl works by promoting late stage erythropoiesis, which increases the number of normoblasts (immature red blood cells in the bone marrow) leading to increased RBC production. With increased RBC production, the symptoms of anemia (extreme fatigue, dizziness, weakness, shortness of breath) are reduced. Reduction of anemia and its symptoms allows patients who have been living with chronic anemia to experience better quality of life, a main goal for many MDS patients. 

Clinical Trials in MDS 

Reblozyl’s first-in-class approval is an important moment in MDS history. Every answer and new therapeutic option gets us one step closer to a cure. 

MDS is not an easy disease to treat as evidenced by the few therapeutic options available to patients. Drug development and clinical trials are massive undertakings that require countless hours, dedicated researchers, and informed patients willing to try something new. Every approval is made possible when individuals who are dedicated to making a difference in the lives of MDS patients work tirelessly until they find an answer. 

If you are interested in participating in a clinical trial and contributing to important MDS research, our Clinical Trial Finder can help you find a trial you qualify for. Contact our dedicated patient navigators if you have any questions about signing up for a clinical trial, or any other MDS related questions: 1-800-709-1113 or at support@healthtree.org