The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Kite Pharma’s CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). The decision comes less than six months after the FDA accepted to analyze, under priority review status, Kite’s biologics license application, shortening review time from the standard 10 months to six months. The therapy also previously received the FDA’s breakthrough therapy status for the same indication. Tecartus will be…
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