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FDA grants breakthrough therapy designation to mosunetuzumab for the treatment of adult patients with R/R follicular lymphoma

Jul 15, 2020

On July 14, 2020, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.

Mosunetuzumab is a bispecific antibody targeting CD3, on the surface of T cells, and CD20, on the surface of B cells. This dual targeting redirects T cells to engage B cells, leading to the lysis and elimination of malignant cells.

The breakthrough therapy designation is based on the promising results of the phase I/Ib GO29781trial ( NCT02500407) investigating mosunetuzumab monotherapy and in combination with other agents in patients with R/R non-Hodgkin lymphoma. In the subgroup of patients with R/R FL, mosunetuzumab showed high response rates and durable complete remissions with a tolerable safety profile.

  1. Roche. FDA grants breakthrough therapy designation for Roche’s CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma. https://www.roche.com/investors/updates/inv-update-2020-07-14b.htm. Published Jul 14, 2020. Accessed Jul 14, 2020.