Amtagvi is a prescription-based tumour-derived autologous T cell immunotherapy and is said to be the first and the only one-time, individualised T cell therapy to get FDA nod for a solid tumour cancer
A product shot of Amtagvi. (Credit: Globenewswire/ Iovance Biotherapeutics, Inc.)
Iovance Biotherapeutics has received US Food and Drug Administration (FDA) accelerated approval for Amtagvi (lifileucel) suspension to treat certain adult patients with advanced melanoma.
Amtagvi is a prescription-based tumour-derived autologous T-cell immunotherapy.
The FDA has approved the medicine for intravenous infusion in adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
The therapy is said to be the first and the only one-time, individualised T-cell therapy to get the FDA nod for a solid tumour cancer.
Iovance interim chief executive officer and president Frederick Vogt said: “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 tumours.
“Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
“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.”
The approval is based on safety and efficacy results from the global, multicentre Phase 2 C-144-01 clinical trial in melanoma patients.
Its efficacy was established based on objective response rate (ORR), and duration of response (DOR) by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary efficacy analysis set included 73 patients from Cohort 4 who were administered the recommended Amtagvi dose, Iovance Biotherapeutics said.
With a median length of response not attained at 18.6 months follow-up, 31.5% of the 73 patients had an objective response by RECIST 1.1.
Furthermore, 153 patients from Cohorts 4 and 2 were included in the supporting pooled efficacy set.
Additionally, 31.4% of the 153 patients had an objective response by RECIST 1.1 with a median duration of response not attained at 21.5 months follow-up.