BMY - FDA investigating serious risk of T-cell malignancies in CAR-T cell therapy patients

2023-11-28 10:52:22 ET

The U.S. Food and Drug Administration (FDA) on Tuesday said it was looking into reports of T-cell malignancies in patients who have been treated with CAR-T cell immunotherapies directed towards the proteins BCMA and CD19.

The regulator said it had determined that the risk of T-cell malignancies applied to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies.

According to the FDA, approved products in this class include: Bristol Myers Squibb's ( NYSE: BMY ) Breyanzi, BMY and 2seventy bio's ( NASDAQ: TSVT ) Abecma, Johnson & Johnson ( NYSE: JNJ ) unit Janssen and Legend Biotech's ( NASDAQ: LEGN ) Carvykti, Novartis' ( NYSE: NVS ) Kymriah, and Gilead Sciences ( NASDAQ: GILD ) unit Kite's Tecartus and Yescarta.

"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 regulator said in a statement .

All gene therapy products in general have some potential risk of developing secondary malignancies. This possibility is included as a class warning label in the prescribing information for approved BCMA-directed and CD19-directed genetically modified autologous T-cell immunotherapies.

The FDA said that the reports it had got of T-cell malignancies included reports of chimeric antigen receptor CAR-positive lymphoma, a type of cancer that begins in the cells of the lymphatic system.

"Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies," the regulator added.

More on CAR-T cell therapies

• Caribou wins FDA orphan drug status for CAR-T therapy
• Galapagos: Navigating Uncharted CAR-T Waters With A Cash Compass
• Legend Biotech: Carvykti Is Sailing High, But Watch The Horizon
• Bristol Myers, 2seventy bio to face FDA AdCom for Abecma label expansion
• Novartis licenses CAR-T candidate from Legend Biotech

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