The FDA has approved an expanded indication for luspatercept (Reblozl) for the first-line treatment of anemia in patients with low-risk MDS who may require blood transfusions.
The FDA has approved luspatercept (Reblozl) for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS) who may need red blood cell (RBC) transfusions and are naïve to erythropoiesis-stimulating agents (ESAs).1
The approval was supported by data from the COMMANDS study, a global phase 3 trial in which 58.5% (n = 86) of patients with lower-risk MDS at risk of anemia who were treated with first-line luspatercept were able to forego transfusions for 12 weeks compared with 31.2% (n = 48) of patients who received epoetin alfa, an ESA. Findings from the trial were presented at the 2023 American Society of Clinical Oncology Annual Meeting.2
“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,” Guillermo Garcia-Manero, MD, lead investigator and chief of the Section of Myelodysplastic Syndromes at the University of Texas MD Anderson Cancer Center, said in a statement. “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.”1
Compared with the current first-line treatment standard of ESAs, luspatercept has shown the capability to decrease the necessary frequency of RBC transfusions and, subsequently, visits to the physician’s office. A major advantage to luspatercept is that injections are only administered once every 3 weeks, compared to weekly injections needed with ESAs.
In the COMMANDS trial, patients were randomized into 2 groups to assess responses to luspatercept and epoetin alfa. The primary end point was transfusion independence for at least 12 weeks, with a mean hemoglobin increase of at least 15 g/dL within the initial 24 weeks of treatment. Secondary end points included a hematologic improvement-erythroid (HI-E) response after at least 8 weeks and transfusion independence at 24 weeks (for at least 12 weeks).
The planned interim analysis included 301 patients who had not yet received ESAs. The luspatercept group showed significantly higher rates of transfusion independence at 12 weeks compared with the group receiving epoetin alfa (58.5% vs 31.2%; P < .0001).
Among the two groups, treatment-emergent adverse events (TEAEs) were reported in 92.1% of luspatercept patients and 85.2% of epoetin alfa, respectively. Additionally, treatment-related AEs were documented by 30.3% of patients receiving luspatercept and 17.6% receiving epoetin alfa.
The drug was previously approved by the FDA for the treatment of adult patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who have anemia failing an ESA and requiring 2 or more RBC units over 8 weeks.3
References
1. U.S. FDA approves Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) as first-line treatment of anemia in adults with lower-risk myelodysplastic syndromes (mds) who may require transfusions. News release. Bristol Myers Squibb. August 28, 2023. Accessed August 29, 2023. https://news.bms.com/news/details/2023/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Reblozyl-luspatercept-aamt-as-First-Line-Treatment-of-Anemia-in-Adults-with-Lower-Risk-Myelodysplastic-Syndromes-MDS-Who-May-Require-Transfusions/default.aspx
2. Caffrey, M. COMMANDS: Luspatercept boosts population with lower-risk myelodysplastic syndromes who are freed from blood transfusions. AJMC. Accessed August 28, 2023. https://www.ajmc.com/view/commands-luspatercept-boosts-population-with-lower-risk-myelodysplastic-syndromes-who-are-freed-from-blood-transfusions
3. FDA approves luspatercept-aamt for anemia in adults with MDS, News release. FDA. April 3, 2020. Accessed August 29, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-luspatercept-aamt-anemia-adults-mds
Dr Kathryn Lindley Explains the Importance of Cardio-Obstetrics in Fellowship Programs
December 5th 2023Kathryn Lindley, MD, FACC, Vanderbilt University Medical Center, talks about why it’s important to incorporate cardio-obstetrics training into cardiovascular disease fellowship programs.
Read More
Imetelstat Offers Benefits for Patients With MDS Who Are Red Blood Cell–Transfusion Dependent
December 5th 2023The past year has offered new hope for patients with lower-risk myelodysplastic syndromes. Besides imetelstat, which has an FDA deadline for action of June 2024, the agency approved luspatercept, which has a different mechanism of action.
Read More
Oncology Onward: A Conversation With Thyme Care CEO and Cofounder Robin Shah
October 2nd 2023Robin Shah, CEO of Thyme Care, which he founded in 2020 with Bobby Green, MD, president and chief medical officer, joins hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, to discuss his evolution as an entrepreneur in oncology care innovation and his goal of positively changing how patients experience the cancer system.
Listen
What We’re Reading: Affordable Home Care; Mycoplasma Infections Rise; Opioid Crisis Settlement
December 4th 2023Families struggle to find affordable, reliable home health aides; reports of increased pediatric pneumonia cases; legal battle ensues over Purdue Pharma’s bankruptcy settlement.
Read More
SABCS 2023 Sessions Touch on "Every Aspect of Breast Cancer"
December 4th 2023The 46th annual San Antonio Breast Cancer Symposium will take place December 5-9, with new and experienced attendees able to choose and learn from a schedule overflowing with the latest developments in breast cancer science and research.
Read More