Gemcitabine news

All news on Gemcitabine (also known as Gemzar): plants, production capacities, investments and involved companies.

10 July 2026

Merck: FDA approves KEYTRUDA and KEYTRUDA QLEX with Padcev for perioperative MIBC

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.
29 June 2026

Genmab: EPCORE DLBCL-4 shows PFS benefit for epcoritamab plus lenalidomide

Phase 3 topline: fixed‑duration subcutaneous epcoritamab + lenalidomide significantly reduced progression/death versus R‑GemOx in relapsed/refractory DLBCL; safety consistent with known profiles.
18 June 2026

Roche: FDA accepts sBLA for subcutaneous Lunsumio VELO plus Polivy in relapsed/refractory LBCL

sBLA accepted based on phase III SUNMO showing 59% reduction in progression risk; FDA decision expected by 9 Feb 2027.
17 June 2026

Genentech seeks FDA approval for Lunsumio VELO plus Polivy in relapsed/refractory LBCL

sBLA accepted for subcutaneous bispecific + ADC combo in relapsed/refractory large B‑cell lymphoma; FDA decision expected Feb 9, 2027.
23 March 2026

Chugai obtains MHLW approval for Lunsumio–Polivy combo in relapsed/refractory large B‑cell lymphoma

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.
16 January 2026

Genmab Reports Phase 3 Trial Results for Epcoritamab in Relapsed/Refractory DLBCL

Epcoritamab shows improved progression-free survival in Phase 3 trial for R/R DLBCL. Safety profile consistent. Further analysis and regulatory discussions planned.

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