Also known as: 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.
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.
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
An experimental ovarian cancer drug, elenagen, more than doubled median survival in a 30-patient mid-stage trial in Belarus. The drug was added to gemcitabine and reduced mortality risk by nearly 60%.
The ASCENT-04 trial shows Trodelvy plus Keytruda extends progression-free survival by 3.4 months in PD-L1-positive metastatic triple-negative breast cancer. Meanwhile, the ToPCourT trial investigates trilaciclib combined with pembrolizumab and chemotherapy for advanced TNBC. These developments signal evolving treatment approaches for this aggressive breast cancer subtype.
Revolution Medicines has initiated patient treatment in the Phase 3 RASolute 303 trial testing daraxonrasib as first-line therapy for metastatic pancreatic cancer. The company also expects top-line data from its Phase 3 RASolute 302 trial in second-line pancreatic cancer in the first half of 2026. Both trials are evaluating the oral RAS(ON) inhibitor in pancreatic ductal adenocarcinoma, a highly lethal cancer with significant unmet medical need.
Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
The FDA has approved Optune Pax, a Tumor Treating Fields device, for use with chemotherapy in locally advanced pancreatic cancer. The approval is based on phase 3 trial data showing improved overall survival and pain progression outcomes. This marks the first new treatment approach for this patient population in approximately 30 years.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07604766 |
An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China |
NOT_YET_RECRUITING | PHASE3 |
| NCT07599423 |
A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Large B-Cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07598318 |
Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07579195 |
Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07575191 |
Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07570823 |
A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07566156 |
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) |
RECRUITING | PHASE3 |
| NCT07564141 |
Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07540390 |
GAPP Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced NPC. |
NOT_YET_RECRUITING | PHASE3 |
| NCT07532902 |
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer |
RECRUITING | PHASE1 |
