Roche announced that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, for the treatment of adult patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL) after two or more lines of systemic therapy, based on results from the phase I/II GO29781 study.

Based on the study results, 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.

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance. With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head, Global Product Development, Roche.

Lunsumio VELO reduces treatment administration time with an approximately one-minute injection, compared with a two to four hour intravenous infusion.

Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.

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

Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorisation of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy.

Roche continues to advance its bispecific antibody programme in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy (polatuzumab vedotin) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL.