Home Medizin FDA genehmigt erste Zelltherapie für metastasiertes Melanom

FDA genehmigt erste Zelltherapie für metastasiertes Melanom

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved Lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) for the treatment of certain adults with inoperable or metastatic melanoma, marking the first approval of a cell therapy for solid tumors.

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

„This approval provides hope for those with advanced melanoma who have progressed following initial standard therapies, as current treatment options are not effective for many patients,“ said Samantha R. Guild, JD, President of AIM at the Melanoma Foundation, in a press release. „This unique cell therapy represents a promising innovation for the melanoma community, and we are excited about its potential to change the care of patients in need of additional therapy options.“

The approval was based on results from the open-label multicenter global clinical trial C-144-01, which demonstrated an objective response rate of 31.5% among 73 patients treated with viable cells within the recommended dosage range of 7.5 x 10^9 to 72 x 10^9. Three patients (4.1%) had a complete response and 20 patients (27.4%) had a partial response.

The median duration of response was not reached after 18.6 months of follow-up. According to an FDA press release, the median time to first response to the therapy was 1.5 months.

„Inoperable or metastatic melanoma is an aggressive form of cancer that can be fatal,“ explained Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, in the FDA announcement. „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.“

„The melanoma community is so grateful to the patients, caregivers, and physicians who enabled the clinical trials of this therapy and brought Lifileucel to approval,“ said Allison Betof Warner, MD, PhD, Director of Melanoma Medical Oncology at Stanford Medicine, in a tweet. „We are thrilled to be able to offer this life-saving therapy to patients as soon as possible! Now available at @StanfordCancer!!!“

For the C-144-01 study, Lifileucel was administered following a lymphodepletion regimen with 60 mg/kg/day cyclophosphamide for 2 days, followed by 25 mg/m² daily fludarabine for 5 days. Between 3 and 34 hours post-infusion, patients received up to six doses of 600,000 IU/kg interleukin-2 aldesleukin at 8–12 hour intervals to support in vivo cell expansion.

The full prescribing information for Lifileucel includes a warning for treatment-related mortality, prolonged severe cytopenia, severe infections, as well as cardiac, pulmonary, and renal dysfunction. The most common adverse reactions occurring in at least 20% of patients were chills, fever, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infections, hypoxia, and dyspnea.

„Patients receiving this product should be closely monitored for signs and symptoms of adverse reactions before and after infusion. Treatment should be withheld or discontinued as appropriate,“ the FDA statement said.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, who writes for Medscape, MDedge, and other partner sites. She currently focuses on oncology but has also written on a wide range of other medical specialties and health topics. She can be reached at sworcester@mdedge.com or on Twitter: @SW_MedReporter.

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