Also known as: fluoropyrimidine
Fluorouracil (5-FU) is a cytotoxic chemotherapy drug in the antimetabolite and pyrimidine analogue classes. It is used systemically for multiple cancers and topically for actinic keratosis and some superficial skin cancers. The drug entered medical use in 1962.
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.
Pfizer reported positive topline PFS results for encorafenib plus cetuximab and FOLFIRI in BRAF V600E-mutant mCRC from BREAKWATER cohort 3. The regimen showed significant PFS improvement and clinically meaningful OS benefit, with no new safety signals.
A Phase 1b/2 trial in 28 patients found nivolumab plus modified FOLFIRINOX was well tolerated before surgery in borderline-resectable pancreatic cancer. Seventy-nine percent proceeded to surgery, with complete tumor removal in all resected patients.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Alphamab Oncology has dosed the first patient in a Phase III study of JSKN003, a biparatopic HER2-targeting ADC, for HER2-positive advanced colorectal cancer. The drug demonstrated a 68.8% response rate in earlier trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07748611 |
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07744126 |
A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07705919 |
DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07678593 |
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07619313 |
AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer |
RECRUITING | PHASE1 |
| NCT07606599 |
A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure |
RECRUITING | PHASE3 |
| NCT07582315 |
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01) |
RECRUITING | PHASE3 |
| NCT07566156 |
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) |
RECRUITING | PHASE3 |
| NCT07543744 |
A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI |
RECRUITING | PHASE1 |
| NCT07490301 |
A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma |
RECRUITING | PHASE2/PHASE3 |
