Also known as: gemcitabine intravesical system, Gemzar
Gemcitabine is a chemotherapy medicine (nucleoside analogue antimetabolite) used to treat multiple solid tumors including pancreatic, lung, breast, ovarian, and bladder cancers. It is administered by intravenous infusion and marketed under the brand name Gemzar and others. The FDA approval history for Gemzar starts in 1996.
ASCO 2026 data show CBM588 boosts immunotherapy in kidney cancer and a bispecific combo improves lymphoma. Early-day ICI infusion, mezigdomide T cell reinvigoration, and dostarlimab maintenance also advance cancer immunotherapy.
Daraxonrasib reduced death risk by 60% versus chemo in Phase 3 pancreatic cancer trial (median OS 13.2 vs 6.7 months). EMA began rolling review; zoldonrasib combo data presented at ESMO GI.
The FDA approved Novocure's Optune Pax for locally advanced pancreatic cancer with gemcitabine and nab-paclitaxel, based on PANOVA-3 data showing improved overall survival. The device also earned a CE mark in Europe, with a planned launch in Germany.
Epcoritamab plus lenalidomide cut progression risk by 60% in R/R DLBCL in a phase 3 trial. Five-year AUGMENT follow-up supports R2 in indolent NHL; a phase 2 penpulimab-lenalidomide-R-GemOx trial showed activity in DLBCL.
The bladder cancer therapeutics market is expanding with recent FDA approvals including INLEXZO for NMIBC and a KEYTRUDA-Padvev combination for MIBC, while the NMIBC market reached approximately USD 3 billion in 2025 across seven major markets. Ferring reported record revenues exceeding €2.5 billion in 2025, driven by Adstiladrin as its second major growth driver. A robust pipeline of emerging therapies is expected to further transform the market through 2036.
Cantargia reported full year 2025 financial results with net sales of SEK 316.7 million and cash of SEK 281.8 million. The company secured a SEK 124 million financing package to advance clinical development of nadunolimab, including a phase Ib study combining it with a RAS inhibitor in pancreatic cancer.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
Soft tissue sarcoma pipeline activity includes 70+ companies and 75+ therapies. A phase II ADI-PEG 20 trial with gemcitabine and docetaxel was designed for sarcomas, while other 2026 studies span synovial sarcoma and unresectable advanced disease.
Neoadjuvant chemoimmunotherapy showed a 51.5% pathological complete response rate in 127 patients with resectable squamous cell lung cancer. Grade 3-4 treatment-related adverse events occurred in 11.8% of patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07769502 |
A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers |
NOT_YET_RECRUITING | PHASE2 |
| NCT07767994 |
AK112 Combined With GAP Conversion Therapy for Locally Advanced Gallbladder Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07748611 |
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07743164 |
A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07741448 |
Neoadjuvant Gemcitabine Plus Trastuzumab Rezetecan in HER2-positive UTUC |
RECRUITING | PHASE2 |
| NCT07710885 |
Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer |
RECRUITING | PHASE3 |
| NCT07705919 |
DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07693959 |
Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC |
RECRUITING | PHASE3 |
| NCT07691515 |
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07685535 |
HAIC + DEB-TACE + Toripalimab + Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma |
NOT_YET_RECRUITING | PHASE2 |
