US FDA has said that the risk of secondary malignancies is applicable to all currently approved BCMA- and CD19-directed genetically modified autologous CAR-T cell immunotherapies, but only one product label, J&J’s Carvykti, has added the safety issue to its existing boxed warning.
Just weeks after a US Food and Drug Administration safety alert across the class of chimeric antigen receptor T-cell (CAR-T) therapies, differences in labeling related to the risk of secondary malignancies are emerging among the six approved products.
Johnson & Johnson and Legend Biotech Corp.’s Carvykti (ciltacabtagene autoleucel) was the first – and to date only...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
