July, 2024
July 2024
Maria Babak: FDA approval to lifileucel for advanced melanoma offers hope to those with limited options
Jul 9, 2024, 08:38

Maria Babak: FDA approval to lifileucel for advanced melanoma offers hope to those with limited options

shared a post by on LinkedIn, adding:

“This is a significant advancement in melanoma treatment, offering hope to those with limited options.

The accelerated approval of lifileucel highlights the potential of innovative therapies in combating challenging diseases.

Find out more about a promising new therapy and the critical safety measures that accompany it in the latest Clinical Monday review by The Babak Lab.”


Clinical Monday FDA Grants Accelerated Approval to Lifileucel for Advanced Melanoma.

The FDA has granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics) for adults with unresectable or metastatic melanoma who have exhausted other treatment options.

This new therapy has shown a 31.5% objective response rate in clinical trials, offering new hope to patients facing this challenging disease.

Key Highlights:

  • New Option
    Approved for patients previously treated with a PD-1 blocking antibody and BRAF/MEK inhibitors.
  • Efficacy
    Demonstrated a 31.5% response rate in trials.
  • Complex Regimen
    Involves chemotherapy, T cell infusion, and IL-2 support.
  • Boxed Warning
    Lifileucel has a Boxed Warning for treatment-related mortality and serious adverse reactions, including severe cytopenia, severe infection, and cardiopulmonary and renal impairment.
  • Adverse Reactions Monitoring
    Common adverse reactions (≥20%) include chills, fever, fatigue, rapid heartbeat, diarrhea, febrile neutropenia, swelling, rash, low blood pressure, hair loss, infection, low oxygen levels, and difficulty breathing.

This approval underscores the importance of innovative treatments in the fight against cancer, providing new avenues for those in critical need.

Find out more details here.”

Maria Babak

Source: Maria Babak/LinkedIn and The Babak Lab/LinkedIn