Whatha, FDA Warns Breakthrough Cancer Treatment Might Cause Cancer

December 1, 2023

In 2017, the U.S. Food and Drug Administration (FDA) approved a breakthrough treatment for blood cancer.

But now, the agency cautions the treatment is not without risks and appears to have caused other cancers in a small number of patients.

The FDA is investigating 19 new cases of cancer occurring in patients who receive CAR-T therapies.

During the treatment, doctors take immune cells from the patient and engineer them to attack tumors, and them insert them into the patient’s bloodstream.

Scientists say the treatment has saved thousands of lives and prolonged others. But when a small number of patients developed new cancers, researchers decided to take a closer look.


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The scientists say it is possible that when the engineered cells are put back into the patient cell DNA is disrupted, leading to the development of new tumors. But the FDA stresses there is no proven link between CAR-T therapy and the 19 cases of new cancers.

The agency says that when you consider how many patients have been helped by the treatment the benefits vastly outweigh the risk.

In October 2017, the FDA approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.

Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL in adults. NHLs are cancers that begin in certain cells of the immune system and can be either aggressive or slow-growing.

“…one in three newly diagnosed cases…”

Approximately 72,000 new cases of NHL are diagnosed in the U.S. each year, and DLBCL represents approximately one in three newly diagnosed cases. 

CAR-T therapy is a type of immunotherapy, similar to the treatment former President Jimmy Carter received seven years ago after he was diagnosed with terminal brain cancer writes Consumer Affairs

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