LUNSUMIO

批准信原文要点

This Prior Approval sBLA provides for updates to subsection 6.1 (Clinical Trials Experience): Addition of Pneumocystis jirovecii pneumonia (Lunsumio USPI); Addition of Pneumocystis jirovecii pneumonia and Epstein-Barr virus infection (Lunsumio Velo USPI).

批准信原文要点

This Prior Approval supplemental biologics license application provides for a new subcutaneous (SC) route of administration of mosunetuzumab-axgb for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

批准信原文要点

This Prior Approval sBLA provides for updates to the United States Prescribing Information (USPI) and Medication Guide (MG) to include updates to: Hemophagocytic Lymphohistiocytosis: Added to Warnings and Precautions (Section 5.4); Neurologic Toxicity: Warnings and Precautions (Section 5.2) expanded to include data on a broader population and title revised to mention Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS); Dosage Modifications for Adverse Reactions revised to include recommendations for Grade 1 neurologic toxicity including ICANS; Patient Labeling Section 17 and MG aligned with revisions to the USPI.