ASTCT Supports the FDA’s Accelerated Approval of AMTAGVI for Treatment of Metastatic Melanoma

CHICAGO, IL / ACCESSWIRE / February 19, 2024 / The American Society for Transplantation and Cellular Therapy® (ASTCT®) supports the decision by the US Food and Drug Administration’s (FDA) to grant accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. The proposed mechanism for AMTAGVI offers a new cell therapy approach that deploys patient-specific T cells called TIL cells. When cancer is detected, the immune system creates TIL cells to locate, attack, and destroy cancer. TIL cells recognize distinctive tumor markers on the cell surface of each person’s cancer. When cancer develops and prevails, the body’s natural TIL cells can no longer perform their intended function to fight cancer 1.

Safety and efficacy were evaluated in a global, multicenter, multicohort, open-label, single-arm trial in patients with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor. Accelerated approval is intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition 2.

Each year, approximately 8,000 people in the U.S. die from melanoma. Until now, there have been no FDA-approved treatment options for patients with advanced melanoma whose disease progressed following initial treatment with an immune checkpoint inhibitor and, if appropriate, targeted therapy 1.

ASTCT invests in research through grants and awards, mentorship for new investigators and congressional advocacy for National Institutes of Health funding. ASTCT is encouraged by the FDA’s announcement for melanoma treatment as the transplantation and cell therapy field continues to be at the forefront of innovation and investigation of CAR-T and TIL cell therapies. The transplantation and cellular therapy community will gather during the 2024 Tandem Meetings of ASTCT® and CIBMTR®, Feb. 21-24, 2024, in San Antonio, to discuss advancements in the field. Representatives from the FDA will be presenting on Saturday, February 24, to share insights on 2023 and 2024 approvals, including AMTAGVI.

“Advancements in CAR-T and TIL cell therapies create a promising future for patients who suffer from solid tumors and have the potential to be lifesaving for patients,” says Miguel-Angel Perales, MD, ASTCT President. “I look forward to our discussion with the FDA during the 2024 Tandem Meetings, as this is a significant announcement for our field and will encourage more research and funding in cell therapy to treat solid tumors.”

More information is available on the Tandem Meetings website. Press can access free registration to participate.

1 Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma


Contact Information

Jennifer Kasowicz
ASTCT Marketing Director
(312) 673-4970

SOURCE: American Society for Transplantation and Cellular Therapy


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