FDA Approvals in the Blood Cancer Space from Early 2024

Here are four recent FDA approvals in the blood cancer space.

In the winter of 2024, the Food and Drug Administration (FDA) approved multiple new therapies in the oncology space — some of which may become the next standard of care, according to experts.

In the blood cancer field, there were three new regimens approved, and another new dosing schedule for a myeloma therapy that, according to one doctor, may be more convenient for patients.

Here at CURE®, we took a look back at all the FDA approvals in the blood cancer space from February to March 2024.

Iclusig Plus chemo for Ph+ ALL

The most recent FDA approval in the blood cancer space was Iclusig (ponatinib) plus chemotherapy for patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

The approval was based on findings from the phase 3 PhALLCON trial, which compared Iclusig to Gleevec (imatinib) in this patient population. Findings showed that the minimal residual disease (small particles of cancer detected after treatment)-negative complete response rate (percentage of patients who have no signs of cancer after induction was 30% in the Iclusig group and 12% in the Gleevec group.

When speaking about the findings at the 2023 School of Hematologic Oncology Annual Meeting, Dr. Elias Jabbour, from The University of Texas MD Anderson Cancer Center said, “This study has established [Iclusig] as the standard of care for Ph-positive ALL.”

Breyanzi for Relapsed/Refractory CLL or SLL

The CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel) was approved for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have been previously treated with two or more therapies, including a BTK inhibitor and BCL2 inhibitor.

In the trial that led to the drug’s approval, 20% of patients treated with Breyanzi experienced a complete response, which is when there were no longer signs of cancer after treatment. “CLL and SLL are currently considered incurable diseases with few treatment options in the relapsed setting that can confer complete responses, something that has historically been associated with improved long-term outcomes,” Dr. Tanya Siddiqi from the City of Hope National Medical Center said.

Brukinsa, Gazyva Combo for Relapsed/Refractory Follicular Lymphoma

On March 7, the FDA approved Brukinsa (zanubrutinib) plus Gazyva (obinutuzumab) for released or refractory follicular lymphoma that has been treated with two or more prior systemic therapies.

The approval came after findings from the BGB-3111-212 (ROSEWOOD) trial showed that the Brukinsa-Gazyva combination outperformed Gazyva alone when it came to overall response rate and duration of response in patients with pretreated relapsed or refractory follicular lymphoma.

Dose Reduction of Tecvayli for Relapsed/Refractory Multiple Myeloma

Tecvayli (teclistamab-cqyv), which was approved in October 2022, can now be administered in a lower dose to patients with relapsed or refractory multiple myeloma who achieved and maintained a complete response for at least six months.

Findings from the MajesTEC-1 trial showed that the lower dose led to similar outcomes as the standard dose (0.06 mg/kg administered via subcutaneous injection on day 1; 0.3 mg/kg on day 4; and 1.5 mg/kg on day 7 followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity).

This new dose may be more convenient to patients, according to Dr. Rachel Kobos, from Johnson and Johnson, who said, “Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules.”

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