FDA Converts Tecartus to Full Approval in Relapsed Mantle Cell Lymphoma
The FDA granted full approval to Tecartus on April 3 2026 for adult patients with relapsed or refractory mantle cell lymphoma based on ZUMA-2 cohort 3 data showing a 91% response rate in BTK-naive patients. Full approval removes payer friction and expands the eligible patient population but increases pressure on CAR-T manufacturing capacity and treatment centre readiness.
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