5-FU (5-fluorouracil) is an antimetabolite fluoropyrimidine chemotherapy agent. Its active metabolites inhibit thymidylate synthase and interfere with RNA/DNA synthesis, producing antitumor effects.
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07532902 |
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer |
RECRUITING | PHASE1 |
| NCT07484724 |
A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma |
RECRUITING | PHASE2 |
| NCT07474727 |
A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
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Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R) |
RECRUITING | PHASE2 |
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Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT07024615 |
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer |
RECRUITING | PHASE1 |
| NCT07014540 |
A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma |
NOT_YET_RECRUITING | PHASE4 |
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Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer. |
RECRUITING | NA |
| NCT06825624 |
ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer |
RECRUITING | PHASE1 |
| NCT06782685 |
Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV |
RECRUITING | PHASE1/PHASE2 |
