Also known as Gemzar.
Phase III ARTEMIS‑011 showed median PFS 5.5 vs 1.4 months (HR 0.33); safety showed high rates of grade ≥3 TRAEs with Ris‑Rez versus chemotherapy.
Phase 3 RAINFOL‑02 shows statistically significant and clinically meaningful PFS and OS benefits versus investigator’s choice chemotherapy in platinum‑resistant ovarian cancer.
EU clears first PD‑1 inhibitor plus ADC regimen for resectable muscle‑invasive bladder cancer regardless of cisplatin eligibility; phase 3 showed EFS HR 0.53 and OS HR 0.65.
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.
