The Center for Biologics Evaluation and Research’s 5 February 2021 approval of Bristol Myers Squibb Company’s chimeric antigen receptor T-cell (CAR-T) therapy Breyanzi is notable not only for its designations – in addition to the RMAT, Breyanzi holds a breakthrough therapy designation – but as the first major product to have been approved after a COVID-19-induced missed user fee goal.
BMS’ Breyanzi Beats COVID-19 Constraints, Emerges As First RMAT Approval
After missing user fee date due to inspection delay, US FDA clears the CAR-T therapy for treatment of adults with relapsed or refractory large B-cell lymphoma.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.