Johnson & Johnson has achieved a  milestone with the approval of CARVYKTI® (ciltacabtagene autoleucel) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma. 

With this advancement, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for multiple myeloma treatment as early as the first relapse.

The FDA's decision is based on positive results from the Phase 3 CARTITUDE-4 study, demonstrating that early use of CARVYKTI® significantly reduces 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, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, also reported key secondary outcomes such as overall response and overall survival.

Dr. Binod Dhakal, Associate Professor at the Medical College of Wisconsin, Division of Hematology and Oncology, commented on CARVYKTI®'s efficacy, stating, "CARVYKTI demonstrated remarkable efficacy as a personalized, one-time infusion in the earlier treatment of relapsed/refractory multiple myeloma as shown through the CARTITUDE-4 study results."

Multiple myeloma, an incurable blood cancer, affects thousands of individuals annually in the United States. With only an estimated 15 percent of patients initially diagnosed with multiple myeloma able to start a fifth line of therapy, the approval of CARVYKTI® provides new hope for patients, expanding access to innovative treatment options.

Dr. Jordan Schecter, Vice President, Disease Area Leader, Multiple Myeloma at Johnson & Johnson Innovative Medicine, expressed the company's commitment to improving outcomes for patients with multiple myeloma. He stated, "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI."

CARVYKTI® is a cell therapy that utilizes a patient's immune system, or T cells, to combat the disease. Since its initial approval in February 2022, Johnson & Johnson has made significant strides in manufacturing to scale CARVYKTI® production, aiming to meet the growing demand for this critical therapy.

Tyrone Brewer, President, US Hematology, Johnson & Johnson Innovative Medicine, emphasized the company's efforts to increase supply and availability of CARVYKTI®. "We understand the urgency for patients in need of CARVYKTI, and we have been making considerable progress in increasing supply and availability in anticipation of this milestone approval," Brewer stated.

While CARVYKTI® offers promising therapeutic benefits, it also carries certain safety considerations, including warnings and precautions for potential adverse reactions. These include cytokine release syndrome, neurotoxicity syndrome, Parkinsonism, Guillain-Barre syndrome, and various other complications.