A Cutting Edge Treatment for Cancer May Cause Rare, Secondary Cancers

A cutting-edge treatment for cancer may be linked to rare, secondary cancers.

The FDA is investigating an alarming finding on a promising cancer therapy invented at Penn Medicine, according to 6ABC-TV in Philadelphia. This therapy is being linked to rare, secondary cancers.

On Tuesday, the FDA announced that it had received “reports of T-cell malignancies or cancers, including a type of lymphoma, in people who received treatment with certain chimeric antigen receptor T-cell or CAR-T therapies,” according to CNN. They have received 19 reports of patients with adverse reactions to treatment.

The CAR-T treatment involves extracting disease-fighting T-cells from a patient, which are then re-engineered to fight cancer and put back in the body.

The statement from the FDA reads, “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action.”

The agency’s announcement also said, “FDA has determined that the risk of T-cell malignancies applies to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class.”

Since 2017, the FDA has approved six commercial CAR-T cell therapies for blood cancers such as lymphomas and leukemias. Researchers are additionally testing these therapies for a variety of other cancers and autoimmune diseases.

Kymriah, the first CAR-T cell therapy, was considered a breakthrough when it was first approved. The FDA’s then commissioner, Scott Gottlieb, said at the time, “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer.”

The cost of Kymriah was a whopping $475,000. Many of today’s CAR-T cell therapies have similar costs.

As with any gene therapy product, the potential risk of developing secondary malignancies is labeled as a class warning in the U.S. prescribing information.