CHMP recommends EU conditional approval of Roche ’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma

If approved, mosunetuzumab would be the first CD20xCD3 T-cell engaging bispecific antibody available to treat follicular lymphoma (FL) offering a new, off-the-shelf, fixed-duration treatment optionThe recommendation is based on the GO29781 study where mosunetuzumab induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pretreated FLBasel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketing authorisation for 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. Bas ed on this positive CHMP opinion, a final decision regarding the conditional approval of mosunetuzumab is expected from the European Commission in the near future. Follicular lymphoma is the second most common form of lymphoma globally, accounting for 20% of all non-Hodgkin lymphomas (NHL) diagnosed worldwide.[1]“The majority of people with follicular lymphoma experience frequent relapses, and with each successive therapy the duration of remission and survival shortens,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s decision acknowl edges the potential of mosunetuzumab as an efficacious, readily ...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news