FDA Approvals in the Blood Cancer Space from Spring 2024

Multiple new regimens have been approved in the blood cancer space this spring.

During the spring of 2024, the Food and Drug Administration (FDA) approved multiple new therapies for patients with hematologic (blood) malignancies. From more CAR-T cell therapies entering the space to new drug combinations, here is a roundup of drug regimens that got OKed by the FDA over the last few months.

Breyanzi for Relapsed/Refractory Follicular Lymphoma

The most recent FDA approval in the blood cancer space was Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory follicular lymphoma that was previously treated with at least two prior therapies.

Breyanzi is a CAR-T cell therapy, which is a kind of drug that involved taking out a patient’s T cells, reengineering them to find and fight cancer, growing them and then infusing them into the body. The approval comes after findings from the phase 2 TRANSCEND-FL trial showed a 95.7% overall response rate — indicating that for most patients, their disease shrunk or disappeared.

Carvykti for Relapsed/Refractory Multiple Myeloma

Carvykti (ciltacabtagene autoleucel; cilta-cel), which is also a CAR-T cell therapy, was approved for patients with relapsed or refractory multiple myeloma that was previously treated with Revlimid (lenalidomide) and a proteasome inhibitor.

The approval came after an FDA committee voted that the benefits of CAR-T cell therapies outweigh the potential risks. Data from the CARTITUDE-4 supported the approval, after demonstrating that Carvykti outperformed the other standard-of-care options when it came to progression-free survival, which is the time patients live before their disease worsens.

Abecma for Pretreated Myeloma

Another CAR-T cell therapy, Abecma (idecabtagene vicleucel; ide-cel), was approved in April for pretreated relapsed/refractory myeloma that underwent at least two lines of therapy.

The KarMMA-3 trial, which led to the approval, showed that at a median follow-up duration of 15.9 months, median progression-free survival was 15.9 months in the Abecma group, compared to 4.4 months for those who received a standard regimen. This equated to a 51% reduction in the risk of disease progression or death, according to the researchers. Additionally, overall response rate was 71% and 39% in the Abecma and standard-of-care groups, respectively.

Iclusig Plus Chemo for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

In March, the FDA granted an accelerated approval to Iclusig (ponatinib) plus chemotherapy for the treatment of patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL).

Data from the PhALLCON trial, which compared Iclusig to Gleevec (imatinib), led to the drug’s approval. Findings showed that 30% of patients given Iclusig experienced minimal residual disease negativity (meaning that no trace of cancer can be found in the blood), compared to 12% in the Gleevec group.

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