Roche Among EU Fast-Track Hopefuls With Lymphoma Bispecific Mosunetuzumab

Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.

The EMA can review marketing applications faster under its accelerated assessment mechanism • Source: Alamy

The European Medicines Agency is expected to decide this week whether to fast track its assessment of the planned EU marketing authorization applications for two investigational products – tabelecleucel (tab-cel) and mosunetuzumab.

Tab‐cel, from Atara Biotherapeutics, is an off-the-shelf, allogeneic T-cell immunotherapy for treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)

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