FDA Approves Iovance Biotherapeutics’ Lifileucel, Revolutionary TIL Therapy for Melanoma Treatment
Pictured: The Iovance Cell Therapy Center/courtesy of Iovance Biotherapeutics
Friday, the FDA granted approval to Iovance Biotherapeutics’ lifileucel as the first one-time cell therapy for a solid tumor and the first tumor-infiltrating lymphocytes (TIL) therapy.
Amtagvi, as lifileucel will be known commercially, was approved under the FDA’s Accelerated Approval pathway, which allows the greenlighting of medicines for serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit.
“The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Revolutionizing Melanoma Treatment – A Look at TIL Therapy
TIL technology has taken nearly four decades to reach maturity. The method was developed by Steven Rosenberg and colleagues at the National Cancer Institute in 1982 using mouse cells; they applied the method to melanoma patients in 1988, and the treatment has shown great efficacy in treating advanced melanoma in animal research and clinical trials.
TIL therapies take advantage of the patient’s own immune cells—lymphocytes—which tend to be suppressed in the tumor environment. These cells can be extracted from tumor biopsies, expanded in numbers or revamped for better efficacy, then transfused back into the patient, leading to antitumor activity.
TILs vs. CAR-T – A Game Changer in Solid Tumor Treatment
Although CAR-T therapies have transformed the way blood cancers are treated, deploying them against solid tumors has proven more challenging. TILs have the advantage of recognizing multiple tumor antigens simultaneously, an ability that CAR-Ts lack. TILs can identify tumor targets derived from intra- or extracellular tumor proteins, making them effective against the heterogeneous nature of solid tumors.
Breakthrough in Treating Advanced Melanoma
With over 75 TIL immunotherapies in preclinical or clinical studies, melanoma has been at the forefront of this treatment modality. Iovance Biotherapeutics has emerged as the pioneer in the field, gaining FDA approval for its TIL therapy against advanced melanoma.
“There are no FDA-approved options for advanced melanoma after the current standard of care,” said Iovance Chief Medical Officer Friedrich Graf Finckenstein. Lifileucel has the potential to redefine the treatment paradigm for these patients.
Meeting Manufacturing Challenges
While the FDA approval is a significant milestone, scaling up manufacturing poses challenges. Currently, TIL production time is around four to six weeks, but efforts are being made to reduce this without compromising the quality of the therapy. Patient-to-patient variation is another hurdle to overcome in scaling up manufacturing.
Iovance Biotherapeutics, however, has pioneered a shorter manufacturing time for lifileucel, reducing it from six weeks to 22 days. The company’s centralized cell therapy center in Philadelphia will help meet the potential rise in demand. However, the cost of TIL therapy remains high until manufacturing scalability is addressed.
Potential Beyond Melanoma
While lifileucel offers hope for melanoma patients, Iovance Biotherapeutics is also exploring TIL therapy’s potential in other solid tumor types. This includes metastatic non-small cell lung cancer (NSCLC) and gynecological cancers.
As companies continue to advance TIL therapy for various indications, a new wave of innovation is expected to tackle all solid tumors.
Aayushi Pratap is a New York-based health and science journalist.
