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FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma


In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

Image credit: Saiful52 | stock.adobe.com

Image credit: Saiful52 | stock.adobe.com

Johnson & Johnson (J&J) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) in earlier lines of treatment for adult patients with relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including both a proteasome inhibitor and an immunomodulatory agent, and who are also refractory to lenalidomide. The 11-0 unanimous vote in favor of the treatment resulted from Phase III CARTITUDE-4 study data, which showed an encouraging risk-benefit evaluation for its proposed indication.1

“We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, VP, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, in a press release. “As a physician and researcher committed to advancing patient care, the potential of Carvykti in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma.”

According to the company, the study evaluated the ability and safety of Carvykti against pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd). The findings suggest that Carvykti offers significant benefits as an earlier line of treatment. The FDA is in the process of reviewing a supplemental Biologics License Application for the medication, expecting to be decided upon by early April.1

“Multiple myeloma is a disease with high unmet need as patients experience relapse or become refractory to treatments over time,” said Sundar Jagannath, MD, director of the Center of Excellence for Multiple Myeloma and professor of Medicine, Hematology and Medical Oncology, Mount Sinai, in the press release. “The availability of a cellular therapy like cilta-cel that can be used earlier in the treatment of this progressive disease is critically important, offering patients a chance of deep and durable responses with a one-time infusion.”

Last December, J&J revealed patient-reported outcomes from the CARTITUDE-4 study, which enrolled a total of 419 patients with lenalidomide-refractory multiple myeloma. After a cutoff, 99 patients were treated with Carvykti and 66 received current standard of care (SOC) treatments. Overall results show that the treatment reduced the risk of disease progression or death by 74%, which was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.2

“These results from the CARTITUDE-4 study showed the potential of cilta-cel to significantly improve health-related quality of life measures for patients, including pain, fatigue and emotional functioning,” said Roberto Mina, assistant professor, Division of Hematology, Department of Molecular Biotechnology and Health Sciences, University of Torino, in a press release.“Cilta-cel has demonstrated deep and durable responses in later lines of therapy, and these results show the potential of cilta-cel for patients with lenalidomide-refractory multiple myeloma as early as after first relapse."


1. U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma. Johnson & Johnson. March 15, 2024. Accessed March 18, 2024. https://www.jnj.com/media-center/press-releases/u-s-fda-oncologic-drugs-advisory-committee-recommends-carvykti-ciltacabtagene-autoleucel-for-the-earlier-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma

2. Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma. Johnson & Johnson. December 11, 2023. Accessed March 18, 2024. https://www.jnj.com/media-center/press-releases/treatment-with-carvykti-ciltacabtagene-autoleucel-resulted-in-clinically-meaningful-improvements-in-health-related-quality-of-life-and-reductions-in-disease-specific-symptoms-in-patients-with-earlier-line-multiple-myeloma

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