Also known as Gemzar.
CHMP recommends approval after KEYNOTE-B15 showed event-free survival, overall survival and pathologic complete response gains; European Commission decision expected Q4 2026.
The trial's sole U.S. primary endpoint—overall survival—did not reach statistical significance; additional results will be submitted for peer review.
FDA clears PD‑1 inhibitor plus antibody‑drug conjugate regimens with enfortumab vedotin as neoadjuvant and adjuvant therapy around cystectomy for adults with muscle‑invasive bladder cancer.
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.
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.
New data shows high survival rates and bladder preservation in BCG-unresponsive NMIBC patients using gemcitabine intravesical system, with minimal severe side effects.
