US FDA requires 'boxed warning' for CAR-T cancer therapies

investing.com:

(Reuters) — The U.S. health regulator said on Monday companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences (NASDAQ:GILD), Johnson & Johnson (NYSE:JNJ), Novartis and others.

Last November, the U.S Food and Drug Administration said it had received reports of patients developing a type of T-cell blood cancer after being treated with genetically modified cells known as chimeric antigen receptor T-cell therapies or CAR-T.

The other cancer therapies include Bristol Myers (NYSE:BMY) Squibb's Breyanzi and its partnered therapy, Abecma, with 2seventy bio, J&J unit Janssen and Legend Biotech's Carvykti, Novartis AG (SIX:NOVN) Kymriah, and Gilead unit Kite's Tecartus and Yescarta.

The treatment generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.

Since 2017, six CAR-T cell therapies have been approved by the FDA, and all are for the treatment of blood cancers, including Lymphomas and some forms of leukemia.

Gilead Sciences, Johnson & Johnson, Novartis, Bristol Myers Squibb, 2seventy bio and Legend Biotech did not immediately respond to Reuters' request for comments.

The so-called boxed warnings are the strictest warnings issued by the FDA regarding the potential serious side effect from the use of a drug.