Mlenny EU regulators are requiring makers of CART T cell therapies to update their product labeling to include information that recipients may be at increased risk for developing secondary T cell cancers. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee evaluated data on 38 cases of secondary T cell malignancies reported among 42K patients who had received CAR T therapies. The committee said testing of tissue samples taken from CAR T patients who later developed secondary T cell cancers indicated the therapies were somehow involved in disease development, according to a statement.
The committee said patients treated with CAR T therapies should be monitored for life for the occurrence of new malignancies. It noted that secondary malignancies have been reported within weeks to up to several years after administration of the therapies. The EMA statement also noted that product information for approved CAR T therapies already includes information advising about the risk of secondary malignancies.
The agency will now require labeling to be updated to include additional information about the risk of secondary T cell malignancies. Currently, there are six CAR T therapies approved for use in the EU: Bristol Myers’ ( NYSE: BMY ) Abecma and Breyanzi, Johnson & Johnson’s ( JNJ ) Carvykti, Novartis’s ( NVS ) Kymriah, and Gilead’s ( NASDAQ: GILD ) Tecartus and Yescarta. Abecma is co-marketed with 2Seventy bio ( TSVT ), while Carvykti is co-marketed wit.
