Tag: mosunetuzumab

Regulatory Approval Healthcare & Pharmaceuticals News

FDA Grants Accelerated Approval to Roche’s One-Minute Lymphoma Injection, Lunsumio VELO™

Roche

The FDA has granted accelerated approval to Roche’s Lunsumio VELO™, a revolutionary subcutaneous formulation for adult patients with relapsed or refractory follicular lymphoma. By reducing administration time from several hours to just one minute, this CD20xCD3 bispecific antibody offers a more flexible, outpatient-friendly treatment option. Supported by a 75% objective response rate in heavily pre-treated patients, Lunsumio VELO marks a major shift toward patient-centered oncology care in 2025.

Oncology Healthcare & Pharmaceuticals News

European Commission Approves Roche’s Subcutaneous Lunsumio for Relapsed or Refractory Follicular Lymphoma

Roche

European Commission has granted conditional approval for the subcutaneous version of Roche’s bispecific antibody, Lunsumio (mosunetuzumab). This new formulation for relapsed or refractory follicular lymphoma offers high rates of deep and durable responses while reducing treatment administration time from several hours to approximately one minute. This enhanced flexibility promises a better treatment experience for patients and streamlined care delivery in clinics.