FDA Approves First Cellular Therapy to Treat Unresectable or Metastatic Melanoma

I was a participant in a trial of the TIL therapy at NIH in 2012 for stage 4 melanoma. I chose to participate in this trial because it was retraining my own immune system to fight my cancer.

Within three months of treatment, 99% of my tumor load was gone (with the remaining was unknown if it was active malignant cells or scar tissue). By 15 months, there was no evidence left.

In the last 11+ years, I've had no further treatment and the melanoma has not returned. I'm very lucky to be a complete responder and have a long-term remission.

When TIL adoptive cell therapy works, it works well. It's amazing, and I'm thankful for Dr. Steven Rosenberg's life work in developing this.

Now that it's FDA approved, many other melanoma patients will have a shot to try a therapy that, for all practical purposes, can be a cure for a disease that not too long ago was a terminal death sentence.

> Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).

> “Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”