FDA Approves Revuforj for Relapsed/Refractory Acute Leukemia Subgroup

The FDA approved Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with the KMT2A translocation.

The Food and Drug Administration (FDA) approved Revuforj (revumenib) for the treatment of adults and children 1 year of age and older with relapsed or refractory acute leukemia with the KMT2A translocation.

It should be noted that translocation refers to the genetic change that occurs when a piece of chromosome breaks off and attaches to another chromosome.

The approval, announced in a notification from the FDA, was based on findings from the AUGMENT-101 study, which enrolled 104 adult and pediatric patients with relapsed or refractory acute leukemia with the KMT2A translocation. Specifically, patients with partial tandem duplications of 11q23 were excluded. Partial tandem duplication is when a segment of DNA is copied and inserted next to the original sequence; this can disrupt normal cellular processes.

Patients in the AUGMENT-101 trial Treated with Revuforj Unacceptable toxicity, disease progression, hematopoietic stem cell transplantation, or failure to achieve morphological leukemia-free status with four courses of treatment, according to the statement. The morphological leukemia-free state is when a patient with leukemia no longer shows any abnormal blood cells or bone marrow cells characteristic of the disease.

The main research interests were complete remission plus complete remission with partial hematological recovery, conversion from transfusion dependence to independence, and duration of complete remission plus complete remission with partial hematological recovery; This is when all symptoms of leukemia disappear. The patient’s blood cell count did not fully recover.

patients in hospital AUGMENT-101 trial21.2% achieved complete remission plus complete remission with partial hematological recovery for an average of 6.4 months. Additionally, of the 22 patients who achieved either partial hematologic recovery or complete response or complete remission, the average time to both was 1.9 months.

The trial findings also showed that 14% of the 83 patients who were dependent on red blood cell and/or platelet transfusions at the start of the trial became independent of red blood cell and/or platelet transfusions within the 56-day period after the start of the trial. hearing according to notification. Additionally, 48% of the 21 patients who were independent of both red blood cell and platelet transfusions at the start of the study remained free of transfusions during this period after the start of the study.

The most common side effects occurring in at least 20% of patients include nausea, bleeding, musculoskeletal pain, elevated phosphate levels, aspartate aminotransferase increased, infection, febrile neutropenia, intact parathyroid hormone increased, alanine aminotransferase increased, diarrhea, bacterial infection. is taking. , QT prolongation, differentiation syndrome, increase in triglycerides, decrease in phosphate, decrease in potassium, constipation, decreased appetite, fatigue, viral infection and increase in alkaline phosphatase.

The FDA noted that the recommended dose of Revuforj may vary depending on the patient’s weight and concurrent use of CPT3A4 inhibitors. In addition, there is also an anticipated delay in the commercial availability of the lowest dose strength of Revuforj for use in patients weighing less than 40 kilograms. Therefore, Revuforj will be available through an expanded access program that allows dose adjustment for these specific patients.

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