HQ Team
February 17, 2024: Iovance Biotherapeutics, a San Carlos, California-based company, has been given the nod for its T-cell therapy to treat melanoma — the most serious form of skin cancer — in adult patients.
The US Food and Drug Administration approved Amtagvi (lifileucel), a cell therapy for patients who had undergone other treatments, for solid tumours that have spread to new parts of the body and cannot be removed surgically.
The FDA’s accelerated approval was based on the overall response rate and duration of response, according to a company statement. Iovance is conducting final clinical trials to confirm the benefit.
Amtagvi is the first and the only one-time, individualized T-cell therapy to receive FDA approval for a solid tumour cancer, according to the statement.
T-cells returned to body
The company’s proprietary process enables it to collect and expand a patient’s unique T cells from a portion of their tumour. The therapy returns billions of the patient’s T cells to the body to fight their cancer.
“The accelerated approval of Amtagvi is the first step in realising Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumours,” said Frederick Vogt, PhD, JD, Interim Chief Executive Officer and President of Iovance.
“We are continuing our development efforts to address additional unmet medical needs in patients with solid tumour cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”
About 8,000 people in the US die from melanoma a year. Until now, there have been no FDA-approved treatment options for patients with advanced melanoma whose disease progressed following initial treatment with an immune checkpoint inhibitor and, if appropriate, targeted therapy.
Expansion underway
Samantha R. Guild, J.D., President, AIM at Melanoma Foundation said: “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”
Amtagvi will be manufactured in Philadelphia at the Iovance Cell Therapy Center, with a capacity for up to several thousand patients annually, including a nearby contract manufacturer.
Additional expansion at iCTC is underway, which will significantly increase this capacity over the next few years, according to the statement.
A boxed warning is attached to the therapy for treatment-related mortality, severe infection, prolonged severe cytopenia, and cardiopulmonary and renal impairment.
The most common side effects of the treatment include chills, fever, low white blood cell count, fatigue, low red blood cell count, fast or irregular heartbeat, rash, low blood pressure, and diarrhoea.
