As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed warning section of each product’s label, according to the agency’s separate notification letters dated Jan. 19 to Bristol Myers Squibb, Gilead Sciences’ Kite Pharma, Johnson & Johnson and Novartis. A black box warning is the most serious safety alert on a medication’s label.
The products involved are Bristol’s Abecma and Breyanzi, Kite’s Yescarta and Tecartus, J&J’s Legend Biotech-partnered Carvykti and Novartis’ Kymriah. The products are separately approved to treat multiple myeloma, large B-cell lymphoma, among other blood cancers…
