Also known as Treanda, Levact, and Ribomustin.
Phase III CELESTIMO showed a statistically significant, clinically meaningful progression‑free survival benefit for Lunsumio plus lenalidomide versus rituximab plus lenalidomide in relapsed/refractory FL after ≥1 prior therapy.
The trial's sole U.S. primary endpoint—overall survival—did not reach statistical significance; additional results will be submitted for peer review.
FDA granted priority review for obinutuzumab in pMN after Phase III MAJESTY showed markedly higher complete remission vs tacrolimus; FDA decision expected Nov 2026.
sBLA accepted for subcutaneous bispecific + ADC combo in relapsed/refractory large B‑cell lymphoma; FDA decision expected Feb 9, 2027.
FDA accepted sBLA for an anti‑CD20 in SLE after Phase III ALLEGORY: SRI‑4 responders 76.7% vs 53.5%, higher remission, fewer flares and steroid reduction; decision due Dec 2026.
