(Reuters) – The European health regulator said on Friday product information for a class of cancer therapies known as CAR-T treatments would be required to highlight risk of secondary blood cancers in patients who use them, ending a five-month safety review.
The European Medicines Agency’s (EMA) mandate, which echoes the one issued by the U.S. health regulator in April, requires manufacturers of CAR-T therapies to include information on their label concerning the risk of a new cancer that begins in a type of white blood cells called T-cells.
The treatments, chimeric antigen receptor T-cell therapies or CAR-T, generally involves extracting immune response-generating T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluated data on 38 cases of secondary T-cell cancers in patients who received CAR-T therapy and identified seven cases where the therapy was involved in disease development.
The committee had announced a safety review in January on therapies including Bristol Myers Squibb’sBreyanzi and its partnered therapy with 2seventy bio, Abecma, Johnson & Johnson and Legend Biotech’s Carvykti, Novartis’ Kymriah, and Gilead Sciences’ Tecartus and Yescarta.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber)
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