Lunsumio FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 6, 2023.
Lunsumio (mosunetuzumab-axgb) is a bispecific CD20-directed CD3 T-cell engager for the treatment of relapsed or refractory follicular lymphoma.
- Follicular lymphoma is a cancer of the lymphatic system in which B lymphocytes (B cells) become cancerous and accumulate in 'follicles' in the lymph nodes. It the most common slow-growing form of non-Hodgkin’s lymphoma.
- Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells. It works by activating and redirecting the T cells to engage and eliminate the target B cells.
- Lunsumio is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Lunsumio carries a Boxed Warning for cytokine release syndrome (CRS), including serious or life-threatening reactions. Warnings and precautions include neurologic toxicity, serious or fatal infections, cytopenias, serious tumor flare reactions, and embryo-fetal toxicity.
- Lunsumio is administered as an intravenous infusion. Due to the risk of CRS patients receive Lunsumio on a "step-up dosing schedule" with smaller doses on day 1 and day 8 of the first cycle of treatment. Each treatment cycle is 21 days and patients usually receive 8 cycles.
- Common adverse reactions include cytokine release syndrome, fatigue, rash, pyrexia, and headache.
Common laboratory abnormalities include decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
Development timeline for Lunsumio
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