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Autologous tumour infiltrating lymphocytes - Iovance Biotherapeutics

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Drug Profile

Autologous tumour infiltrating lymphocytes - Iovance Biotherapeutics

Alternative Names: Autologous expanded tumour infiltrating lymphocytes - Iovance Biotherapeutics; LN 145; LN-145-S1; MDA Autologous TILs; MDA Autologous Tumor Infiltrating Lymphocytes; MDA-TIL; MDA-TILs; TIL LN-145

Latest Information Update: 23 Sep 2025

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At a glance

  • Originator National Cancer Institute (USA); National Institutes of Health (USA)
  • Developer Iovance Biotherapeutics; National Cancer Institute (USA); National Institutes of Health (USA); University of Texas M. D. Anderson Cancer Center; Yale University
  • Class Antineoplastics; Immunotherapies; Tumour infiltrating lymphocyte therapies
  • Mechanism of Action Immunologic cytotoxicity; Lymphocyte replacements
  • Orphan Drug Status

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

    Yes - Cervical cancer
  • New Molecular Entity No

Highest Development Phases

  • Phase III Non-small cell lung cancer
  • Phase II Adenocarcinoma; Cervical cancer; Colorectal cancer; Head and neck cancer; Malignant melanoma; Osteosarcoma; Ovarian cancer; Soft tissue sarcoma; Triple negative breast cancer
  • Phase I Solid tumours

Most Recent Events

  • 05 Jun 2025 Case Comprehensive Cancer Center withdraws a phase I trial in Malignant melanoma (Late-stage disease) in USA (IV) prior to enrolment as Iovance withdrew support due to length of time required to meet accrual goal (NCT06190249)
  • 09 May 2024 US FDA has a type D meeting with Iovance Biotherapeutics providing a positive regulatory feedback on the proposed potency matrix before May 2024
  • 28 Mar 2024 Phase-I clinical trials in Solid tumours (Recurrent, Second-line therapy or greater) in USA (IV) (NCT06566092)

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