Last reviewed 2026-04-20 · How we verify

LIFILEUCEL

Lifileucel is a marketed therapy for unresectable or metastatic melanoma, positioning it in a critical segment of oncology treatments. Its key strength lies in its unique mechanism of action, which differentiates it from existing therapies. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Unresectable or Metastatic Melanoma

Boxed warnings

• WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3 for 3 consecutive days, or per institutional standard. Treat severe infections [see Warnings and Precautions (5.1 , 5.4) ]. Monitor cardiopulmonary and renal functions throughout the treatment course. [see Warnings and Precautions (5.1 , 5.5 , 5.6 , 5.7) ]. Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available [see Dosage and Administration (2.1) , and Adverse Reactions (6.1) ] . WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT See full prescribing information for complete boxed warning. Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage ( 5.1 , 5.2 , 5.3 ) Treat severe infections ( 5.1 , 5.4 ) Monitor cardiopulmonary and renal functions throughout the treatment course ( 5.1 , 5.5 , 5.6 , 5.7 ) Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available ( 2.1 , 6.1 )

Common side effects

• chills
• pyrexia
• fatigue
• tachycardia
• diarrhea
• febrile neutropenia
• nausea
• edema
• weight increased
• infection with pathogen unspecified
• decreased appetite
• headache

Key clinical trials

• Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma (PHASE2)
• SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (PHASE3)
• Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients (PHASE1)
• A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (PHASE1)
• A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma (PHASE2)
• A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel (PHASE1, PHASE2)
• A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer. (PHASE2)
• A Study of LN-144 in People With Metastatic Melanoma to the Brain (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.