EC 621-248-1
FDA backs first adjuvant immunotherapy regimen for stage III dMMR colon cancer after ATOMIC showed a 50% reduction in recurrence or death with Tecentriq added to chemotherapy.
The trial's sole U.S. primary endpoint—overall survival—did not reach statistical significance; additional results will be submitted for peer review.
Phase 3 topline: fixed‑duration subcutaneous epcoritamab + lenalidomide significantly reduced progression/death versus R‑GemOx in relapsed/refractory DLBCL; safety consistent with known profiles.
sBLA accepted based on phase III SUNMO showing 59% reduction in progression risk; FDA decision expected by 9 Feb 2027.
sBLA accepted for subcutaneous bispecific + ADC combo in relapsed/refractory large B‑cell lymphoma; FDA decision expected Feb 9, 2027.
FDA accepted an sBLA for adjuvant PD‑L1 therapy plus chemotherapy in stage III dMMR/MSI‑H colon cancer; agency decision expected Oct 9, 2026.
Japan approves Lunsumio + Polivy for relapsed/refractory large B‑cell lymphoma after Phase III SUNMO: ORR 69.7%, PFS 11.5 vs 3.8 months (59% lower progression/death risk); manageable safety.
Epcoritamab shows improved progression-free survival in Phase 3 trial for R/R DLBCL. Safety profile consistent. Further analysis and regulatory discussions planned.
Columvi with GemOx doubles survival in R/R DLBCL patients, approved in 50+ countries, offering a non-transplant treatment option.
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