LOS ANGELES, California – After nearly four decades since its inception, the first TIL therapy has received accelerated approval from the Food and Drug Administration for advanced melanoma. This immunotherapy, which harvests cancer-fighting immune cells from the patient’s own body, is called Amtagvi or lifileucel from Iovance, and is the first cell therapy approved for a solid tumor.
Allison Betof Warner, a cell therapy researcher and physician at Stanford University, expressed her excitement and gratification, calling this a game-changing moment for the field. She emphasized the significant success of cellular therapy for hematologic malignancies and the potential for capitalizing on that success for solid tumors with the approval of Amtagvi.
In a phase 2 clinical trial titled C-144-01, 153 patients who had already undergone a median of three prior lines of therapy received lifileucel, with 31% of them responding to the therapy. Betof Warner highlighted the promising aspect of the therapy, stating that 42% of patients who responded were still showing positive responses for 18 months or longer.
The approval of Amtagvi marks a significant advancement in the treatment of advanced melanoma, offering hope to patients who have exhausted standard care options. This development opens the door for the potential approval of more cell therapies for solid tumors in the future.
Experts in the field are hopeful that this milestone will pave the way for further innovation and progress in the treatment of solid tumors, bringing much-needed relief to patients and their families. The success of Amtagvi signals a new era in cancer treatment, with the potential to impact the lives of many individuals affected by advanced melanoma.