Roche Secures EU Nod for Lunsumio SC One-Minute Injection

Roche has received conditional marketing approval in Europe for Lunsumio, a new subcutaneous form of its bispecific antibody that can be administered in a quick, one?minute injection.

This approval marks one of the significant changes in the management of relapsed or refractory follicular lymphoma in adults, especially those who have already had at least two prior systemic therapies.

The choice can be justified by the results of the Phase I/II GO29781 trial that demonstrated that subcutaneous dose of Lunsumio yields similar drug levels in the body compared to intravenous dose. The research also did not indicate any unforeseen safety concerns and this has resulted in an alternative formulation that will substitute the two-to-four hour IV injections with a fast outpatient injection.

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Its subcutaneous form is very appealing to clinics and cancer centres as it is drastically lowering the chair time and maintaining the same level of durability as with the IV therapy. Past statistics established that 57 percent of totally remitted patients under the IV formulation continued with their remission five years after, which speaks volumes of its longevity.

Roche is pursuing additional world wide approvals including the U.S. and is developing drug trials like MorningLyte, that compares Lunsumio SC with lenalidomide in patients previously untreated with follicular lymphoma. Besides Columvi, these attempts empower the expanding CD20xCD3 bispecific portfolio of Roche and reinforce the transition of the company towards faster and more flexible cancer therapies.