FDA Approves Johnson & Johnson’s Innovative, Immuno-Targeted Multiple Myeloma Therapy, CARVYKTI

Johnson & Johnson

HORSHAM, PA — In a significant medical breakthrough, Johnson & Johnson recently announced FDA’s approval of CARVYKTI® for the treatment of adult patients with multiple myeloma. This approval marks a significant milestone as CARVYKTI® becomes the first and only B-cell maturation antgen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma, a form of incurable blood cancer.

The approval is based on the positive results from the Phase 3 CARTITUDE-4 study which demonstrated that the early use of CARVYKTI® significantly lessened the risk of disease progression or death by 59 percent compared to standard therapies in adults with relapsed and lenalidomide-refractory multiple myeloma. The study also revealed encouraging key secondary results such as overall response (OR) and overall survival (OS).

“CARVYKTI demonstrated remarkable efficacy as a personalized, one-time infusion in the earlier treatment of relapsed/refractory multiple myeloma,” said Binod Dhakal, M.D., Associate Professor at the Medical College of Wisconsin. He also expressed excitement for patients who may now have the opportunity for a treatment-free period for their multiple myeloma as early as first relapse.

With an estimated 35,000 new cases of multiple myeloma predicted to be diagnosed in 2024 in the United States, this approval brings new hope for patients. Real-world studies show that only an estimated 15 percent of patients initially diagnosed with multiple myeloma are able to start a 5th line of therapy. However, this approval will grant more patients access to this cutting-edge treatment.

“This significant event firmly highlights our commitment to improving patient outcomes and transforming the treatment of multiple myeloma with CARVYKTI,” stated Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.

CARVYKTI® employs a unique approach to therapy by harnessing a patient’s own immune system, or T cells, to fight the disease. Extensive training, preparation, and certification are required to ensure a positive experience for patients undergoing this treatment. Since initial approval in 2022, Johnson & Johnson has made remarkable advances in manufacturing to rapidly scale CARVYKTI® production.

Reiterating the commitment, Tyrone Brewer, President, U.S. Hematology, Johnson & Johnson Innovative Medicine said, “We understand the urgency for patients in need of CARVYKTI. We have made considerable progress in increasing supply and availability in anticipation of this milestone approval, more than doubling the manufacturing of CARVYKTI in 2023, striving to double again in 2024.”

However, CARVYKTI® does come with a boxed warning for Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) amongst other complications. The most common nonlaboratory adverse reactions include pyrexia, hypogammaglobulinemia, hypotension, and musculoskeletal pain.

Despite the risks, the approval of CARVYKTI® provides a crucial new weapon in the fight against multiple myeloma. It offers a beacon of optimism for innumerable patients and their families battling this challenging disease.

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