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Ciltacabtagene autoleucel - Janssen Biotech/Nanjing Legend Biotech

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: 22 Mar 2024

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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

  • 22 Mar 2024 U.S Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends approval of Ciltacabtagene autoleucel for Multiple myeloma (Second-line therapy or greater for patients who have received at least one prior line of therapy) in USA
  • 11 Mar 2024 Launched for Multiple myeloma (Second-line therapy or greater) in Austria (IV)
  • 11 Mar 2024 Launched for Multiple myeloma (Second-line therapy or greater) in Germany (IV)
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