Roche's Lunsumio Subcutaneous Formulation Recommended for EU Approval
- CHMP recommends EU approval for subcutaneous Lunsumio for relapsed follicular lymphoma.
- Subcutaneous Lunsumio reduces administration time to one minute compared to 2-4 hours IV.
- Phase II GO29781 study shows pharmacokinetic non-inferiority and low cytokine release syndrome.
- Data submitted to global health authorities, including the US FDA, for approval consideration.
CHMP Recommendation
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous formulation of Lunsumio for treating adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. A final decision from the European Commission is anticipated soon.
Study Findings
The recommendation is based on the phase II GO29781 study, which demonstrated that subcutaneous Lunsumio has pharmacokinetic non-inferiority compared to intravenous administration. The study also reported a low rate and severity of cytokine release syndrome, with all events resolving in a median of two days.
Administration Benefits
Subcutaneous Lunsumio significantly reduces treatment administration time to approximately one minute, compared to 2-4 hours for intravenous infusion. It is designed for a fixed duration of 6-12 months, depending on patient response, and can be initiated in an outpatient setting.
Global Approval Efforts
Data from the phase II study have been submitted to other health authorities worldwide, including the US Food and Drug Administration, for approval consideration.
Source: Roche