Also known as Rituxan and MabThera.
Phase 3 trial of subcutaneous T‑cell‑engaging bispecific with R‑CHOP cut progression/death risk by 51% in newly diagnosed DLBCL (IPI 2–5); safety consistent with known profiles.
FDA clears pirtobrutinib for newly diagnosed CLL/SLL patients without 17p deletion after BRUIN CLL-313 showed a large PFS benefit versus bendamustine–rituximab.
Interim analysis shows a significant progression‑free survival benefit versus rituximab+lenalidomide in second‑line or later relapsed/refractory follicular lymphoma; safety as expected.
Phase III CELESTIMO interim analysis showed a statistically significant, clinically meaningful PFS benefit versus rituximab+lenalidomide; OS immature; safety consistent with known profiles.
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.
First bispecific‑based, chemotherapy‑free second‑line option in Europe after Phase 3 showed major PFS benefit and high complete response rates.
Phase 3 topline: fixed‑duration subcutaneous epcoritamab + lenalidomide significantly reduced progression/death versus R‑GemOx in relapsed/refractory DLBCL; safety consistent with known profiles.
Approval adds adult-onset indication with specified IV dosing; Phase III showed 87.4% relapse‑free at Week 49 versus 38.0% for placebo; safety consistent with prior data.
