The FDA has accepted a supplemental Biologics License Application for moving up the use of Abecma, a CAR-T cell therapy, for adult patients with multiple myeloma.
Patients may soon have faster access to a CAR-T cell therapy for multiple myeloma.
The Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) to treat certain patients with multiple myeloma, according to an announcement from biopharmaceutical company Bristol Myers Squibb and immuno-oncology cell therapy company 2seventy bio, Inc.
Abecma had previously been approved by the FDA for patients who received at least four prior lines of therapy; the manufacturers’ current application takes the number of prerequisite therapies down to three.
Abecma is a cell-based gene therapy customized with a patient’s own T cells which are collected, genetically modified to target and kill myeloma cells, and infused back into the patient.
“Our continued focus on bringing Abecma into earlier lines of treatment demonstrates our commitment to increasing treatment options and improving outcomes for patients living with multiple myeloma,” Anne Kerber, senior vice president and head of cell therapy development at Bristol Myers Squibb, said in the news release. “This FDA acceptance marks another step forward in our mission by bringing us closer to offering this potentially transformative, one-time CAR T treatment option to more patients.”
The FDA accepted the application based on the results from the KarMMA-3 study, which investigated the treatment of adult patients with relapsed and refractory multiple myeloma who received an immunomodulatory antibody, a proteasome inhibitor and an anti-CD38 monoclonal antibody according to the press release from the two companies, which are co-developing and co-promoting the treatment.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of Dec. 16, by which time the agency plans to make a decision on the application according to Monday’s news release.
Abecma made headlines in 2021 ago as the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma, and KarMMA-3’s findings that Abecma significantly improved progression-free survival (the time that a patient lives without disease progression) for patients with pretreated, relapsed and refractory multiple myeloma were announced in 2022 by Bristol Myers Squibb.
“Positive results from our Phase 3 KarMMa-3 study demonstrate a significant clinical benefit of Abecma across lines of care in triple-class exposed multiple myeloma,” Dr. Steve Bernstein, chief medical officer of 2seventy bio, said in the news release. “The acceptance of the sBLA brings us closer to expanding the benefits of Abecma to myeloma patients earlier in their treatment course.”
According to the press release, the most common side effects outside of a laboratory setting include cytokine release syndrome (an influx of inflammatory molecules, called cytokines), infections, fatigue, musculoskeletal pain, hypogammaglobulinemia (low antibody levels), diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy (altered brain function), swelling, fever, cough, headache and decreased appetite.
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