Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the
Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the
It is also the first non-CAR-T adoptive cell therapy to reach the market. Based on the
Dr
Importance of the FDA’s approval
"This landmark FDA approval reflects significant advancements in tumour infiltrating lymphocytes (TIL) therapy cell therapy since we initially showed that TIL cells isolated from patients with metastatic melanoma could be expanded in the lab and returned to the patient to mediate cancer regression," shared Dr
According to
"So far, we haven't seen great success from CAR-T or other cell therapies in treating patients with solid tumours. However, by the very nature of TILs, we have years of data demonstrating them to be more successful for these cancer types," Dr
"Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalised, one-time therapeutic option for these patients," remarked
"This welcome news represents an important step forward in harnessing cell therapy to treat solid tumours," explained
Clinical efficacy of the immunotherapy Amtagvi
"One-time treatment with AMTAGVI offered clinically meaningful and deep, durable responses in the Phase II clinical trial, and I am excited by its potential as a much-needed new treatment option for the many advanced melanoma patients who progress on the current standard of care," noted Dr
In the clinical study, the safety and effectiveness of Amtagvi was evaluated in adults with unresectable or metastatic melanoma given at least one systemic therapy, including a PD-1 blocking antibody, and if positive for the BRAF V600 mutation, a BRAF inhibitor or BRAF inhibitor with an MEK inhibitor.
FDA highlighted that among the 73 patients treated with Amtagvi at the recommended dose:
- Objective response rate was 31.5 percent, including three (4.1 percent) patients with a complete response and 20 (27.4 percent) patients with a partial response
- In patients responsive to lifileucel, 56.5 percent, 47.8 percent and 43.5 percent continued to maintain responses without tumour progression or death at six, nine and 12 months, respectively.
Manufacturing the novel cellular therapy
According to
The FDA granted the approval of Amtagvi to
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