Lunsumio VELO Has Been Approved for R/R FL

The US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.

Approval is based on the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75 percent and 59 percent, respectively. The median duration of response was 22.4 months. The most common adverse reactions (≥20 percent) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhea. The CRS rate was 30 percent, and events were mostly low grade (grade 1-2, 28 percent; grade 3, 2.1 percent), occurred during cycle 1 and all resolved after a median duration of two days (range: 1-15). CRS can be severe and life-threatening.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Ian Flinn, MD, PhD, of Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”