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FDA Approves Groundbreaking CAR T Cell Therapy, Abecma, for Multiple Myeloma


6 April 2024

The US FDA has approved Abecma, a novel CAR T cell therapy by Bristol Myers Squibb and 2seventy bio, for adults with relapsed or refractory multiple myeloma after two prior therapies. Demonstrating significant improvement in progression-free survival in the KarMMa-3 trial, this one-time infusion offers new hope for patients.

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved a novel CAR T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of multiple myeloma. This groundbreaking treatment is specifically for adult patients with relapsed or refractory multiple myeloma who have undergone at least two prior therapies, marking a pivotal shift in the management of this complex disease.

Abecma represents a new class of therapy known as CAR T cell therapy, a revolutionary approach that harnesses the patient's immune system to fight the cancer more effectively. This one-time infusion treatment has demonstrated remarkable efficacy in the KarMMa-3 trial, significantly prolonging progression-free survival times and reducing the risk of disease progression or death by 51% compared to standard regimens.

“Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb.

Abecma is now available earlier in the treatment journey for patients who have been exposed to and relapsed after the three main classes of multiple myeloma treatments: immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies. This expansion of indication means that more patients can benefit from this innovative therapy sooner, potentially altering the course of their disease in a profoundly positive way.

“We are extremely pleased that Abecma will be available to many more patients in the US. This approval represents another important milestone for patients, for Abecma, and for 2seventy bio as we remain committed to increasing treatment options and working to improve outcomes for patients living with multiple myeloma,” said Chip Baird, chief executive officer, 2seventy bio.

Manufacturing success rates and capacity for Abecma have been commendably high, according to Bristol Myers Squibb, ensuring that this vital treatment will be accessible to the patients who need it. Furthermore, the therapy's approval in other regions, including Japan, Switzerland, the European Union, Great Britain, and Israel, highlights its global impact on the treatment landscape for multiple myeloma.

Multiple myeloma is characterized by the uncontrolled proliferation of plasma cells in the bone marrow, leading to a host of debilitating symptoms and complications. Despite advancements in medical treatments, achieving long-term remission remains a significant challenge, with patients often experiencing relapses or becoming refractory to current therapies.

KarMMa-3 Pivotal Trial Results

The KarMMa-3 trial, a pivotal Phase 3 study, assessed Abecma's efficacy against standard regimens in relapsed and refractory multiple myeloma patients who had undergone 2-4 previous treatments, including those 94% refractory to daratumumab. Abecma significantly outperformed standard treatments, tripling progression-free survival (PFS) to a median of 13.3 months compared to 4.4 months, and reduced the risk of disease progression or death by 51%. The trial also allowed for crossover to Abecma, showcasing its effectiveness and the potential for improved patient outcomes.


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