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The streamlined process is expected to shorten the turn-around for the CAR-T therapy to about the same time as from an office visit to front-line cancer treatment, Kite Pharma said.
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.
Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.
CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.
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