FDA Approves Amtagvi as First T-Cell Therapy for Solid Tumor

Iovance Biotherapeutics Receives FDA Approval for Individualized Tumor-Infiltrating Lymphocyte Therapy

Iovance Biotherapeutics has recently made history by receiving FDA approval for Amtagvi, the first individualized tumor-infiltrating lymphocyte (TIL) therapy for solid tumors. Priced at $515,000 per patient, Amtagvi is slightly higher in cost than existing CAR-T cell therapies but has shown promising results in shrinking tumors in patients with advanced melanoma who have undergone previous treatments.

The therapy, manufactured using immune cells from individual patients, equips the body with cancer-fighting immune cells. It is only available for patients with resectable tumors and has a boxed warning for potential side effects. Iovance has on-boarded 30 designated centers for treatment and plans to expand to over 50 centers within the next 100 days.

The company is well-prepared for the launch, with sufficient manufacturing capacity to potentially serve several thousand patients annually. Payers have shown appreciation for the value proposition of Amtagvi, with the company expecting to secure coverage similar to existing CAR-T therapies.

A phase 3 trial is currently underway to confirm Amtagvi’s clinical benefit in patients with untreated melanoma. The approval for Amtagvi was achieved after a long and challenging journey, but Iovance successfully navigated hurdles and secured FDA approval under the accelerated pathway.

In addition to Amtagvi, Iovance is also working on another TIL therapy for post-PD-1 non-small cell lung cancer, currently in phase 2 testing. These groundbreaking therapies mark a significant advancement in personalized cancer treatment and offer hope for patients with difficult-to-treat solid tumors.

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