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Ciltacabtagene autoleucel - Janssen Biotech/Nanjing Legend Biotech

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Drug Profile

Ciltacabtagene autoleucel - Janssen Biotech/Nanjing Legend Biotech

Alternative Names: BCMA CAR-T - Janssen Biotech; BCMA CAR-T cell therapy- Janssen Biotech/Nanjing Legend Biotech; CAR-T cell therapy - Nanjing; CARVYKTI; cilta-cel; JNJ 4528; JNJ-68284528; LCAR-B38M; LCAR-B38M CAR-T cell therapy; LCARB38M/JNJ-4528

Latest Information Update: 09 Dec 2025

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At a glance

  • Originator Legend Biotech USA; Nanjing Legend Biotech
  • Developer Janssen Biotech; Legend Biotech USA; Nanjing Legend Biotech
  • Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Multiple myeloma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase II Smoldering multiple myeloma

Most Recent Events

  • 06 Dec 2025 Updated efficacy data from the phase-III CARTITUDE-4 trial in Multiple myeloma released by Legend Biotech
  • 12 Nov 2025 European Commission and US FDA updates label for ciltacabtagene autoleucel to include overall survival benefit versus standard of care
  • 20 Oct 2025 Nanjing Legend Biotech and Janssen Research & Development discontinue the phase II CARTIFAN-1 trial for Multiple Myeloma (Second-line therapy or greater) in China (IV), due to a strategic realignment of the sponsor's business plan, not related to safety, efficacy, or data integrity concerns , (NCT03758417)

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