Ciltacabtagene autoleucel

Ciltacabtagene autoleucel, sold under the brand name Carvykti, is a medication used to treat multiple myeloma.[1][2]

Ciltacabtagene autoleucel
Clinical data
Trade namesCarvykti
Other namesJNJ-68284528
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank
UNII
KEGG

The most common adverse reactions include pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting.[2]

Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.[1][2] Each dose is customized using the recipient's own T-cells, which are collected and genetically modified, and infused back into the recipient.[1][2]

Ciltacabtagene autoleucel was approved for medical use in the United States in February 2022.[2][3][4]

Medical uses

Ciltacabtagene autoleucel is indicated for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[1][2]

History

The safety and efficacy of ciltacabtagene autoleucel were evaluated in CARTITUDE-1 (NCT03548207), an open label, multicenter clinical trial evaluating ciltacabtagene autoleucel in 97 participants with relapsed or refractory multiple myeloma who received at least three prior lines of therapy which included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and who had disease progression on or after the last chemotherapy regimen; 82% had received four or more prior lines of antimyeloma therapy.[1][2]

The U.S. Food and Drug Administration (FDA) granted the application for ciltacabtagene autoleucel priority review, breakthrough therapy, and orphan drug designations.[2]

Society and culture

On 24 March 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Carvykti, intended for the treatment of adults with relapsed and refractory multiple myeloma.[5][6] The applicant for this medicinal product is Janssen-Cilag International NV.[5]

References
  1. "Carvykti- ciltacabtagene autoleucel injection, suspension". DailyMed. 9 March 2022. Retrieved 16 March 2022.
  2. "FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 7 March 2022. Retrieved 16 March 2022. This article incorporates text from this source, which is in the public domain.
  3. "Carvykti". U.S. Food and Drug Administration (FDA). 8 March 2022. Retrieved 16 March 2022.
  4. "U.S. FDA Approves Carvykti (ciltacabtagene autoleucel), Janssen's First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma". Janssen Pharmaceutical Companies (Press release). 1 March 2022. Retrieved 16 March 2022.
  5. "Carvykti: Pending EC decision". European Medicines Agency. 24 March 2022. Retrieved 25 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. "New gene therapy to treat adult patients with multiple myeloma". European Medicines Agency (EMA) (Press release). 25 March 2022. Retrieved 25 March 2022.


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