Monday, 22 April, 2024
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FDA approves first cell therapy for metastatic melanoma

The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval of a cellular therapy in the solid tumour setting.

Specifically, the tumour-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 (PD-1)–blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without an MEK inhibitor.

“The approval for this one-time cell therapy offers hope to those with advanced melanoma who have progressed after initial standard of care therapies, as the current treatment options are not effective for many patients,” said Samantha Guild, president of the Melanoma Foundation.

Medscape reports that the approval was based on findings from the open-label single-arm global C-144-01 clinical trial, which showed an objective response rate of 31.5% in 73 patients treated within the recommended dosing rage of 7.5 x 109 to 72 x 109 viable cells. Complete responses occurred in three patients (4.1%) and partial responses occurred in 20 patients (27.4%).

Median duration of response was not reached at 18.6 months of follow-up. The median time to initial response to the therapy was 1.5 months, according to an FDA statement.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research. “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.”

For the C-144-01 trial, lifileucel was administered after a lymphodepletion regimen of 60 mg/kg/d of cyclophosphamide for two days followed by 25 mg/m2/d of fludarabine for five days. Between three and 34 hours after infusion, patients received 600 000 IU/Kg of the interleukin 2 aldesleukin every 8-12 hours for up to six doses to support cell expansion in vivo.

The full prescribing information for lifileucel contains a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions, which occurred in at least 20% of patients, were chills, pyrexia, fatigue, tachycardia, diarrhoea, febrile neutropenia, oedema, rash hypotension, alopecia, infection, hypoxia and dyspnoea.

“Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated,” said the FDA.


Medscape article – FDA Approves First Cellular Therapy for Metastatic Melanoma (Open access)


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