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Afamitresgene autoleucel - US WorldMeds

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Drug Profile

Afamitresgene autoleucel - US WorldMeds

Alternative Names: ADP A2M4; afami-cel - adaptimmune; MAGE-A4 SPEAR T-cell therapy; MAGE-A4 TCR; MAGE-A4-SPEAR-T-cell-therapy-Adaptimmune; MAGE-A4c1032T; MAGE-A4ᶜ¹º³²T; Melanoma-associated antigen A4-specific T-cells - Adaptimmune; TECELRA

Latest Information Update: 26 Jun 2026

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At a glance

  • Originator Adaptimmune
  • Class Antineoplastics; Gene therapies; Immunotherapies; T lymphocyte cell therapies
  • 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 - Soft tissue sarcoma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Synovial sarcoma
  • Phase II Myxoid liposarcoma
  • Phase I/II Neuroblastoma; Neurofibrosarcoma; Osteosarcoma

Most Recent Events

  • 22 Jun 2026 Registered for Synovial sarcoma (In adolescents, Late-stage disease, Second-line therapy or greater, Inoperable/Unresectable, Metastatic disease) in USA (IV)
  • 22 Jun 2026 US FDA grants full approval for Afamitresgene autoleucel for Synovial sarcoma (In adults, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater)
  • 02 Jun 2026 Efficacy, adverse events and pharmacokinetics data from the SPEARHEAD-1 phase II trial and SPEARHEAD-3 phase I/II trial in Synovial sarcoma presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO-2026)

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