Roche's Lunsumio SC Approved in EU for Relapsed Follicular Lymphoma
- Lunsumio SC is approved for relapsed or refractory follicular lymphoma after two or more systemic therapies.
- Approval is based on phase I/II GO29781 study results showing pharmacokinetic non-inferiority to IV administration.
- Lunsumio SC reduces administration time to approximately one minute.
- No unexpected safety signals were observed in the study.
Approval and Indication
The European Commission has granted conditional marketing authorization for Lunsumio® (mosunetuzumab) subcutaneous (SC) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This decision is based on the results from the phase I/II GO29781 study.
Study Findings
The study demonstrated that Lunsumio SC has pharmacokinetic non-inferiority compared to intravenous (IV) administration. Importantly, no unexpected safety signals were observed during the study, supporting the treatment's safety profile.
Administration Benefits
Lunsumio SC offers a significant reduction in treatment administration time, allowing for a one-minute subcutaneous injection compared to the traditional 2-4 hour IV infusion. This new method can be initiated in an outpatient setting, providing greater convenience for patients.
Source: Roche