Clinical Bristol Myers' data makes a case for earlier use...

Bristol Myers’ data makes a case for earlier use of a bone marrow disease drug


Bristol Myers’ Reblozyl has surpassed Epogen in treating anemia caused by myelodysplastic syndromes. The results came from a detailed analysis of the trial, which supports the use of Bristol Myers Squibb medicine for a bone marrow cancer-like illness, potentially providing doctors with a new treatment option.

The findings, presented in a study abstract, provide more information about Bristol Myers’ successful announcement in October.

The medicine, luspatercept, is already licensed in the United States to treat anemia caused by myelodysplastic syndrome. However, it is only approved for use when prior therapies have failed and is limited to specific individuals with certain illness features.

The trial compared luspatercept to one of those earlier medications, Amgen’s Epogen, in slightly over 350 individuals with low-risk MDS who had never been treated before. Bristol Myers Squibb stated that their medicine helped more patients avoid blood transfusions for anemia and increased levels of the oxygen-carrying protein hemoglobin.

According to the data, 59% of research participants treated with luspatercept were not transfused for a period of approximately 90 days, compared to 31% on Epogen. Participants were required to have an increase in hemoglobin levels to meet the criteria for the study’s primary goal.

According to Professor Olatoyosi Odenike of the University of Chicago, there is optimism regarding the potential of luspatercept as a viable therapy for anemia related to lower-risk MDS.

The lead investigator of the study, Guillermo Garcia-Manero, who is a leukemia professor at MD Anderson Cancer Center, emphasized that patients treated with luspatercept experienced prolonged periods without requiring transfusions compared to those using Epogen. He asserts that medications such as Epogen provide temporary relief, whereas the findings of the study favor the effectiveness of luspatercept.

MDS occurs when the bone marrow fails to produce enough healthy blood cells and instead generates immature cells known as blasts. This can result in low levels of red blood cells, white blood cells, platelets, and acute myeloid leukemia.

Anemia is the most common symptom of MDS and is the main focus of medications being developed to treat the disease.

The findings of the Bristol-Myers research represent the first time that a new pharmaceutical has proven to be superior as an initial MDS treatment compared to treatments like Epogen, which are collectively known as erythropoietin-stimulating agents or ESAs, due to their ability to stimulate red blood cell production.

Both luspatercept and Epogen exhibited side effects, although the luspatercept group reported a relatively higher occurrence of treatment-related adverse events. During the trial, four participants in the luspatercept group developed leukemia, while five individuals on Epogen faced the same outcome. The mortality rate was approximately 18% for both groups.

Bristol Myers reported first-quarter US sales of $158 million for the medicine. It expects that peak annual global sales will exceed $4 billion by 2030.

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