Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.
Kite Pharma, Inc.’s CAR-T therapy Tecartus will remain an outlier among its peers when new safety labeling on secondary malignancy is in place, but will be much less of one after a quick change by the US Food and Drug Administration.
Officials in the Center for Biologics Evaluation and Research had released mandates to the sponsors of six CAR-T therapies indicated...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
