Posted by Michael Wonder on 15 Jul 2020
FDA grants breakthrough therapy designation for Roche's CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
14 July 2020 - Tenth breakthrough therapy designation awarded for Roche's haematology medicines.
Roche today announced that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted breakthrough therapy designation by the US FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
This designation was granted based on encouraging efficacy results observed in the phase I/Ib GO29781 study investigating mosunetuzumab in relapsed or refractory non-Hodgkin's lymphoma. The safety profile of this T-cell engaging bispecific was consistent with its mechanism of action. Results from this study were previously presented at the American Society of Hematology 2019 Annual Meeting.
