EU regulator requires secondary cancer risk warning for CAR-T therapies

Exterior of EMA, European Medicines Agency is seen in Amsterdam

(Reuters) -The European health regulator said on Friday cancer cell therapies known as CAR-T treatments must include a written warning of an associated risk for secondary blood cancers in patients who use them and that patients should be monitored for life.

The European Medicines Agency's (EMA) directive from its Pharmacovigilance Risk Assessment Committee echoes the one issued by the U.S. health regulator in April and follows a five-month safety review.

Manufacturers of CAR-T therapies - a bespoke process in which patient T-cells are removed, modified to fight cancer and then reinfused - will now be required to include the information on their label. Their review found new cancers that begin in a type of white blood cells called T-cells.

Johnson & Johnson, Bristol Myers Squibb and Gilead Sciences are among the makers of CAR-T therapies.


The EMA committee 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 cases were reported out of the 42,500 people who have been treated with the therapy, it said.

The panel found that secondary T-cell cancers have been reported within weeks and up to several years following administration of CAR-T, or chimeric antigen receptor T-cell therapy, medicines.

The EMA panel had announced a safety review in January on therapies including Bristol's Breyanzi and its partnered therapy with 2seventy bio, Abecma, J&J and Legend Biotech's Carvykti, Novartis' Kymriah, and Gilead's Tecartus and Yescarta.

Earlier this year, the U.S Food and Drug Administration imposed its strongest "boxed warning" on CAR-T therapies for risk of secondary blood cancers and also required lifelong monitoring for a new cancer.

As part of its review, the FDA found that secondary T-cell cancers have been reported in conjunction with five of the six available CAR-T therapies.

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.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shailesh Kuber)