Roche has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of a new subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (R/R FL) after two or more lines of systemic therapy.
The recommendation follows positive results from the phase 2 GO29781 study, which found pharmacokinetic non-inferiority compared to intravenous (IV) formulations.
Lunsumio is a first-in-class bispecific antibody designed to simultaneously target CD20 on B cells and CD3 on T cells. The SC formulation aims to streamline administration and improve patient experience.
According to Roche, SC injections can be delivered in around one minute, compared with several hours for intravenous infusion. Treatment duration follows the same six- to 12-month fixed course as the infusion formulation but can be administered in an outpatient setting.
Levi Garraway, Roche’s chief medical officer and head of global product development said: “Lunsumio was the first-ever approved CD20xCD3 T-cell engaging bispecific antibody demonstrating high, durable response rates and a favourable safety profile in third-line or later follicular lymphoma.
“If approved, the subcutaneous formulation could help to expand the treatment options available, offering people a fixed-duration therapy with a faster treatment administration time.”