EU regulator starts safety review of CAR-T cancer cell therapies
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-01-15 03:30 GMT | Update On 2024-03-27 08:46 GMT
The European Union's drug watchdog has said it had started a review into the safety risks associated with cancer cell therapies made by companies such as Novartis and Gilead Sciences.The treatment for different types of blood cancer, known as chimeric antigen receptor T-cell therapies or CAR-T, generally involves extracting disease-fighting white blood cells known as T-cells from a...
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The European Union's drug watchdog has said it had started a review into the safety risks associated with cancer cell therapies made by companies such as Novartis and Gilead Sciences.
The treatment for different types of blood cancer, known as chimeric antigen receptor T-cell therapies or CAR-T, 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.
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) said it will review data on secondary malignancies or the development of an additional type of cancer related to the T-cells, after patients use the medicines.
The U.S. Food and Drug Administration is also investigating six of these therapies approved in the EU.
These include Bristol Myers Squibb's Breyanzi and its partnered therapy, Abecma, with 2seventy bio. J&J unit Janssen and Legend Biotech's Carvykti, Novartis' Kymriah, and Gilead unit Kite's Tecartus and Yescarta are also a part of the review, the EMA said.
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