EC approves Roche’s Lunsumio

The European Commission has granted conditional marketing authorization of Roche’s (ROG: SIX) Lunsumio (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

The Swiss pharma giant noted that the approval is based on results from the phase I/II GO29781 study, which showed that Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous (IV) administration, with no unexpected safety signals.3

“Building on the benefits of its fixed-duration dosing schedule, Lunsumio can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients,” he added.