FDA grants Breakthrough Therapy Designation for Roche ’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma

Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies.“We are pleased that the FDA has granted Breakthrough Therapy Designation to mosunetuzumab, recognising the promising early efficacy data for this molecule and the remaining unmet need in follicular lymphoma,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Pr oduct Development. “Indeed, we are excited by the potential of both our CD20xCD3 bispecific antibodies – mosunetuzumab and glofitamab – in development for difficult-to-treat lymphomas, and remain committed to developing innovative therapies to improve outcomes for patients.” This designation was granted based on encouraging efficacy results observed in the phase I/Ib GO29781 study [NCT02500407] investigating mosunetuzumab in R/R non-Hodgkin lymphoma (NHL). 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. BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions ...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news