by Megan Giboney – RegMedNet –
The US FDA has granted accelerated approval for AMTAGVI™ (lifileucel), a novel cell therapy for advanced melanoma. This is the first cell therapy to be approved by the FDA for the treatment of a solid tumor.
AMTAGVI utilizes a population of immune cells called tumor-infiltrating lymphocytes (TILs). These cells are created by the immune system in response to cancer and they can recognize distinctive tumor markers and penetrate into the tumor. To manufacture AMTAGVI, TILs are isolated from a portion of a patient’s resected tumor and expanded ex vivo before being reinfused back into the patient to fight their cancer. AMTAGVI effectively replenishes the body with these anti-cancer immune cells, compensating for the diminished efficacy of naturally occurring TILs over time.