STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear
“We do have secondary primary malignancy discussions with patients in the context of transplant and will have to do for CAR-T as well,” a myeloma physician says after the FDA…
The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy.
While the label means that physicians will have to have a conversation about secondary malignancies occurring after Carvykti treatment, oncologists and CAR-T experts said the label update won’t change anything about the use of Carvykti.
“I do not believe this particular change will have any bearing on patient care,” said Saad Usmani, a myeloma physician and cell therapist at Memorial Sloan Kettering who has also studied Carvykti. That’s partly because physicians already discuss the risk of second cancers due to other cancer therapies including radiation, some targeted therapies, and some chemotherapies, which are necessary in the use of CAR-T. “We do have secondary primary malignancy discussions with patients in the context of transplant and will have to do for CAR-T as well,” Usmani said.
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