Blood Cancer Approvals from Summer 2023

The treatment landscape for patients with blood cancers is constantly changing, with new therapies being investigated and gaining Food and Drug Administration (FDA) approval, which allows them to be introduced into the market in the United States. This provides patients with hematologic malignancies more options — and better outcomes — than ever before.

Here is a look back at all the drugs that were FDA approved in the blood cancer space during the summer of 2023.

Reblozyl for anemia in patients with myelodysplastic syndrome

The FDA recently approved Reblozyl (luspatercept-aamt) for the treatment of anemia (low red blood cell counts) in patients with very low- to intermediate-risk myelodysplastic syndrome (MDS) who require blood transfusions and have not previously been treated with an erythropoiesis-stimulating agent.

The approval was based on findings from the phase 3 COMMANDS trial, which showed that more than half of patients given Reblozyl became independent of transfusions for at least 12 weeks. Additionally, 47.6% of patients were independent of red blood cell transfusions at 24 weeks.

Elrexfio for pretreated relapsed/refractory myeloma

Patients with heavily pretreated (four or more prior lines of therapy) relapsed or refractory multiple myeloma may have a new treatment option, thanks to the FDA’s August approval of Elrexfio (elranatamab-bcmm), a drug that is injected under the skin and activates immune cells to kill myeloma cells.

Dr. Alexander M. Lesokhin, from Memorial Sloan Kettering Cancer Center, spoke with CURE® about the approval (which is based on findings from the phase 2 MagnetisMM-3 trial) saying, “I have patients on these drugs that were enrolled in the trials that have been on them for a year and a half or more, who continue to work and continue to function, and you wouldn't even know that have myeloma.”

Vanflyta-based regimen for FLT3 ITD-positive acute myeloid leukemia

In July, the FDA approved Vanflyta (quizartinib) plus cytarabine and anthracycline induction and then cytarabine consolidation for the maintenance treatment of patients with newly diagnosed FLT3 ITD-positive acute myeloid leukemia (AML). The FDA also approved the LeukoStrat CDx FLT3 Mutation assay as a companion diagnostic to determine which patients are eligible for this regimen.

Data from the QuANTUM-First clinical trial led to the approval, after findings showed that the average duration of response for patients given Vanflyta plus induction chemotherapy was 38.6 months, compared with 12.4 months in patients given placebo plus induction chemotherapy.

Fixed-duration Columvi for relapsed/refractory diffuse large B-cell lymphoma

Columvi (glofitamab-gxbm) was approved in June to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma that resulted in follicular lymphoma after two or more lines of therapy, marking the first and only bispecific antibody treatment with a fixed duration that is available for this patient population.

The approval is based on findings from the phase 1/2 NP30179 clinical trial, which showed that 56% of patients responded to treatment with Columvi, including 43% who had a complete response, meaning that all signs of cancer disappeared.

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