Overview

• On 18 September, the EMA’s CHMP adopted a positive opinion to add subcutaneous administration, a solution-for-injection form, and new 5 mg and 45 mg strengths for Lunsumio.
• The opinion is based on the phase II GO29781 primary analysis showing pharmacokinetic non-inferiority versus intravenous dosing, an ORR of 74.5% and a CR rate of 58.5%, with a median CR duration of 20.8 months.
• Safety data reported no unexpected signals; cytokine release syndrome occurred in 29.8% of patients (Grade 1–2, 27.7%; Grade 3, 2.1%), typically during cycle 1 and resolving, with injection-site reactions (60.6%) and fatigue (35.1%) also common.
• The subcutaneous option could cut administration to an approximately one‑minute injection versus 2–4 hour infusions, with fixed‑duration therapy of about 6–12 months that can begin in outpatient settings.
• The change would apply to Lunsumio’s monotherapy use in adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies, which remains under conditional authorisation, orphan status, and additional monitoring in the EU; Roche has also submitted data to regulators including the FDA.