June 14 (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 ( JNJ ), Bristol Myers Squibb ( BMY ) and
Gilead Sciences ( GILD ) 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 ( LEGN )
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.