A cancer treatment that uses a patient’s immune cells may also cause cancer, the FDA said this week. The agency told drugmakers to add a solid warning to their labels about this risk.
The treatment is called CAR-T therapy. It stands for chimeric antigen receptor T cell therapy. It helps patients with some blood cancers, like leukemia, multiple myeloma, and lymphoma. These cancers are hard to treat with other methods.
CAR-T therapy works by changing some of the patient’s immune cells, called T cells, in a lab. The transformed cells can find and kill cancer cells in the body. Then, the cells are put back into the patient.
Many patients have benefited from CAR-T therapy. Some doctors even said it cured two leukemia patients who got the treatment 10 years ago.
However, the FDA said there is a chance that CAR-T therapy can also cause a rare type of blood cancer. The agency said it got 25 reports of this happening. It also said two studies in a medical journal called “Blood” showed the same risk.
Carly Kempler, who works for the FDA, said the warning does not mean CAR-T therapy is terrible. She said the treatment still helps more than it harms.
Bruce Levine, a cancer expert at the University of Pennsylvania, said the FDA had to act because of the new evidence. He said the risk is shallow, but it is essential to inform patients and doctors.
The FDA sent letters to six drugmakers who make CAR-T therapy products. They are Novartis, Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson, and others. The letters said the drugmakers have to change their labels in 30 days. They have to add a boxed warning, the most vital kind of warning.
Drugmakers disagree with the FDA, but they have to explain why
Novartis said it does not think its product causes cancer. But it said it will follow the FDA’s request and change its label. The other drugmakers said they will also work with the FDA. Bristol Myers Squibb said it has not seen any cancer cases with its product. It said it cares about patient safety.
Some people wonder if CAR-T therapy can cause cancer. CAR-T therapy is a new way of treating some cancers using the patient’s immune cells. But we don’t know if CAR-T cells can make new cancers grow in the body.
The FDA is watching this closely. They want the companies that make CAR-T therapy to follow the patients for 15 years and see if they get any other cancers. (Other cancers are cancers that are different from the one that was treated.)
The FDA is not saying that CAR-T therapy is causing other cancers. They are just saying that there might be a link.
This is how the FDA works. They look for any signs of trouble.
But even if CAR-T therapy can cause other cancers, the chance is probably meager. Dr. Hemant Murthy, a cancer doctor at the Mayo Clinic, said that more than 27,000 people have gotten CAR-T therapy in the U.S. He said this will not change how he treats his patients.
Dr. SaadUsmani, another cancer doctor at Memorial Sloan Kettering, said that doctors already talk to their patients about the possibility of getting other cancers from cancer treatments. He noted that other treatments, like radiation and chemotherapy, can also cause other cancers.
He said the FDA’s warning is unsurprising because there have been some reports of other cancers after CAR-T therapy. But he said that this is very rare.
Dr. Marcela Maus, a cancer researcher at Harvard and Mass General, said doctors might be more careful but still use CAR-T therapy. She said that they have to focus on the cancer that the patient has right now. She said this would not make a big difference in their practice.
