FDA Approves Another Gene Immunotherapy Treatment For Cancer

The Food and Drug Administration OK'd a second gene immunotherapy treatment. It's for adults with certain types of non-Hodgkin lymphoma.
Posted at 5:00 PM, Oct 20, 2017

The U.S. Food and Drug Administration approved the second gene immunotherapy treatment for cancer in two months.

The new therapy, called Yescarta, is geared toward adult patients with certain aggressive types of non-Hodgkin lymphoma.

In August, the FDA cleared the first gene therapy for leukemia to hit the market, clinically tested on mostly children and teens.

Medical experts herald the emerging immunotherapy as a breakthrough in treating cancer and possibly other types of diseases.

"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases," FDA Commissioner Scott Gottlieb said. "In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer."

Gene therapy works by taking cells from the patient's body and genetically modifying them to attack cancerous cells. The altered cells are then reintroduced into the patient.

The treatment is only authorized for patients who've unsuccessfully undergone at least two other alternative treatments.

Although the complete remission rate in clinical trials for Yescarta was 51 percent, the FDA does warn there could be severe side effects and is requiring the manufacturer to conduct further studies on patients.

And it's expensive, with a U.S. list price of $373,000.

Still, as one immunotherapy expert puts it, FDA approval of Yescarta will likely save thousands of lives in the next few years.