FDA grants accelerated approval to immunotherapy for unresectable or metastatic melanoma
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Key takeaways:
- The approval of Amtagvi was based on positive safety and efficacy results from the C-144-01 clinical trial.
- Amtagvi becomes the first FDA-approved T cell therapy for a solid tumor cancer.
The FDA has granted accelerated approval to a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma.
According to a release from Iovance Biotherapeutics, accelerated approval was based on safety and efficacy results from the C-144-01 clinical trial, a global, multicenter study investigating Amtagvi (lifileucel) in 73 individuals with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy.
According to data reported in the release, 31.5% of study enrollees treated with Amtagvi achieved an objective response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) with a median duration of response not reached at 18.6 months follow up, while median time to initial response to Amtagvi was 1.5 months.
Additionally, among 153 patients in a separate cohort, 31.4% achieved an objective response by RECIST 1.1 with a median duration of response not reached at 21.5 months follow-up (54.2% of responses had a duration greater than 12 months).
“The accelerated approval of Amtagvi is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” Frederick Vogt, PhD, JD, interim CEO and president of Iovance, said in the release. “We are continuing our development efforts to address additional unmet medical needs in patients with solid tumor cancers, making our novel cell therapies available to more patients with melanoma and other types of cancers.”
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