Lifileucel is the first cellular therapy to be approved to treat patients with unresectable or metastatic melanoma.
Specifically, the tumor-derived autologous T-cell immunotherapy is indicated for adult patients previously treated with a programmed cell death protein 1 –blocking antibody, and ifThe approval "offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients," Samantha R. Guild, JD, president, AIM at Melanoma Foundation, stated in a press release.
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 press release. "The melanoma community is so grateful to the patients, caregivers, and clinicians who have made the clinical trials of this therapy possible and got lifileucel to approval," Allison Betof Warner, MD, PhD, director of Melanoma Medical Oncology at Stanford Medicine,for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment.
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