Regorafenib

(Stivarga)

Regorafenib

Drug updated on 11/9/2023

Dosage FormTablet (oral; 40 mg)
Drug ClassKinase inhibitors
Ongoing and Completed StudiesClinicalTrials.gov

Indication

  • For the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an antiVEGF therapy, and, if RAS wild-type, an anti-EGFR therapy
  • For the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate
  • For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Product Monograph / Prescribing Information

Document TitleYearSource
Stivarga (regorafenib) Prescribing Information.2020Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Regorafenib for previously treated metastatic colorectal cancer.2023NICE
Baseline Albumin-Bilirubin grade as a predictor of response and outcome of regorafenib therapy in patients with hepatocellular carcinoma: a systematic review and meta-analysis. 2023BMC Cancer
Comparison of the efficacy and safety of third-line treatments for metastatic colorectal cancer: a systematic review and network meta-analysis. 2023Frontiers in Oncology
Regorafenib compared to nivolumab after sorafenib failure in patients with hepatocellular carcinoma: A systematic review and meta-analysis. 2023Advances in Clinical and Experimental Medicine
Second‑line treatments for advanced hepatocellular carcinoma: a systematic review and bayesian network meta‑analysis. 2022Clinical and Experimental Medicine
Health-related quality of life and side effects in gastrointestinal stromal tumor (GIST) patients treated with tyrosine kinase inhibitors: a systematic review of the literature. 2022Cancers
The prognostic role of neutrophil-to-lymphocyte ratio and C-reactive protein in metastatic colorectal cancer using regorafenib: a systematic review and meta-analysis.2022Journal of Gastrointestinal Oncology
The role of regorafenib in the management of advanced gastrointestinal stromal tumors: a systematic review.2022Cureus
Cost-Effectiveness Analysis of Tyrosine Kinase Inhibitors in Gastrointestinal Stromal Tumor: A Systematic Review. 2021Frontiers in Public Health
Comparative efficacy and safety for second-line treatment with ramucirumab, regorafenib, and cabozantinib in patients with advanced hepatocellular carcinoma progressed on sorafenib treatment: a network meta-analysis.2021Medicine
Immune-checkpoint inhibitors for metastatic colorectal cancer: a systematic review of clinical outcomes.2021Cancers
Optimizing survival and the changing landscape of targeted therapy for intermediate and advanced hepatocellular carcinoma: a systematic review.2021Journal of the National Cancer Institute
A systematic review and network meta-analysis of second-line therapy in hepatocellular carcinoma.2020Current Oncology
Systematic review and network meta‑analyses of third‑line treatments for metastatic colorectal cancer.2020Journal of Cancer Research and Clinical Oncology
Systemic therapy and sequencing options in advanced hepatocellular carcinoma: a systematic review and network meta-analysis. 2020JAMA Oncology
Efficacy and safety of regorafenib in combination with chemotherapy as second-line treatment in patients with metastatic colorectal cancer: a network meta-analysis and systematic literature review.2020Advances in Therapy
Cardiovascular diseases in patients receiving small molecules with anti-vascular endothelial growth factor activity: a meta-analysis of approximately 29,000 cancer patients.2020European Journal of Preventive Cardiology
Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis. 2020Cancers
Systematic review and network meta-analyses of third-line treatments for metastatic colorectal cancer. 2020Journal of Cancer Research and Clinical Oncology
Efficacy and safety of regorafenib as beyond second-line therapy in patients with metastatic colorectal cancer: an adjusted indirect meta-analysis and systematic review. 2020Therapeutic Advances in Medical Oncology
A systematic review and network meta-analysis of regorafenib and TAS-102 in refractory metastatic colorectal cancer.2019The Oncologist
A Comparison of regorafenib, fruquintinib, and TAS-102 in previously treated patients with metastatic colorectal cancer: a systematic review and network meta-analysis of five clinical trials.2019Medical Science Monitor
Final clinical guidance report: regorafenib (Stivarga).2018CADTH
Beyond second-line therapy in patients with metastatic colorectal cancer: a systematic review.2018Annals of Oncology
A meta-analysis of safety and efficacy of regorafenib for refractory metastatic colorectal cancer.2018Medicine

Clinical Practice Guidelines