After undergoing surgery, radiation and three different therapies, Scott Goedeke faced a tough reality: The cancer that first surfaced on the roof of his mouth had spread to a lymph node in his neck. So the 58-year-old health-care consultant agreed to an experimental treatment that would deploy his own cells to destroy it.

“I have to do this,” he recalled thinking at the time.

His medical team at the Siteman Cancer Center in St. Louis extracted one tumor, identified the cells that could attack the disease and multiplied them in a lab. Billions of cells were then infused back into his body in the hope of supercharging his body’s natural defenses, overwhelming the cancer.

Six weeks later, the tumor had shrunk significantly.

Now this first-of-its-kind cancer therapy has crossed a major milestone. On Friday, the U.S. Food and Drug Administration approved its use to treat adults with a skin cancer like Goedeke’s – melanoma that has spread or can’t be removed with surgery, after other approaches have failed. Though the condition is uncommon, cancer experts say winning FDA approval could mark the beginning of a potent new weapon against far more common tumors.

Shares of Iovance Biotherapeutics, the California-based company that makes the therapy, surged more than 30% on Tuesday, the first full day of trading following the FDA’s approval.


“The concept that the FDA has now acknowledged is that you can use a patient’s own cells as a living drug to treat their disease, and that to me is a very exciting step forward,” said Steve Rosenberg, a senior investigator for the National Cancer Institute who has helped pioneer the newly approved therapy since the 1980s. “It’s the start of a new era in the development of a new approach to treating cancer,” he said, describing ongoing research regarding more common deadly tumors such as those in breast, pancreatic and colon cancer.

Scientists have for decades worked to develop cancer treatments that exploit the body’s own immune system to seek out and destroy malignant tumors. This field has produced breakthroughs in recent years, including drugs that help the body recognize and attack cancer cells. Another tool, approved by the FDA in 2017, extracts the body’s cancer-killing cells and programs them to attack a particular kind of blood-based tumor.

The new individualized therapy, called tumor-infiltrating lymphocytes, enlists the relatively small number of the body’s T cells that see a tumor as a threat and produces a lab-grown army of them. Of the 73 patients treated in a clinical trial, 31.5% of them had their tumors decrease in size or disappear after the cell treatment, the FDA said.

The FDA approval “represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement Friday.

Iovance Biotherapeutics has priced the therapy, branded Amtagvi, at $515,000 per patient. The FDA approval 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 tumors,” Iovance interim chief executive Frederick Vogt said in a statement Friday.

The FDA action is also a signal to the pharmaceutical industry that there is a commercial path to success, said Jason Bock, chief executive of CTMC, a company spun out of MD Anderson Cancer Center that contracts with biotech firms to help manufacture cell therapies. The approval, he said, “was 40 years in the making” for “one of the most complex therapeutics we’ve ever tried to develop.”


Goedeke, the cancer patient, went through chemotherapy to prepare his body for the cell therapy. He remembers the day his cells were infused back into his body – Jan. 25, 2023 – at Siteman Cancer Center. They came in a special container. The procedure took perhaps half an hour, and was followed by other infusions to help the body put the new cells to work.

After he was discharged from the hospital, Goedeke met with his oncologist to discuss the results of the latest scan for cancer. These visits were always stressful, and Goedeke’s wife joined him.

George Ansstas, a Washington University oncologist at Siteman, broke the news six weeks after the therapy: Goedeke was a “responder” to the experimental therapy.

“I don’t think I can overstate the relief and exhilaration,” Goedeke said. “We couldn’t get out to the car fast enough to share the news.”

Of the FDA’s approval, he said, “I’m super happy other patients will be able to access this.”

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