Regorafenib - Bayer Healthcare

Alternative Names: BAY-734506; fluoro-sorafenib; Resihance; Stivarga

Latest Information Update: 19 Jul 2024

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At a glance

Originator Bayer HealthCare
Developer ARCAGY/GINECO Group; Bayer HealthCare; Bayer Zydus Pharma; Bristol-Myers Squibb; British Columbia Cancer Agency; Global Coalition for Adaptive Research; Jiangsu Hengrui Medicine Co.; Memorial Sloan-Kettering Cancer Center; Merck Sharp & Dohme; Ono Pharmaceutical; Spanish Cooperative Group for Digestive Tumour Therapy; University of Pittsburgh
Class Amides; Antineoplastics; Eye disorder therapies; Fluorobenzenes; Phenylurea compounds; Pyridines; Small molecules
Mechanism of Action Bcr-Abl tyrosine kinase inhibitors; EphA2 receptor antagonists; Mitogen-activated protein kinase 11 inhibitors; Platelet-derived growth factor receptor antagonists; Proto oncogene protein c raf inhibitors; Proto-oncogene protein b-raf inhibitors; Proto-oncogene protein c-kit inhibitors; Proto-oncogene protein c-ret inhibitors; Raf kinase inhibitors; Receptor protein-tyrosine kinase antagonists; TIE-2 receptor antagonists; TrkA receptor antagonists; Type 1 fibroblast growth factor receptor antagonists; Type-2 fibroblast growth factor receptor antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists; Vascular endothelial growth factor receptor-3 antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Liver cancer; Gastrointestinal stromal tumours
New Molecular Entity Yes

Marketed Colorectal cancer; Gastrointestinal stromal tumours; Liver cancer
Phase III Glioblastoma
Phase II Adenoid cystic carcinoma; Biliary cancer; Cholangiocarcinoma; Ovarian cancer; Pancreatic cancer; Renal cell carcinoma; Solid tumours
No development reported Acute myeloid leukaemia; Rhabdomyosarcoma
Discontinued Non-small cell lung cancer; Wet age-related macular degeneration

31 May 2024 Efficacy and adverse event data from the phase I/II REGOMUNE trial in Solid tumours presented at the 60^th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)
31 May 2024 Efficacy, pharmacodynamics and adverse events data from a phase II trial in Liver cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASC0-2024)
23 Apr 2024 Bayer in collaboration with Merck Sharp & Dohme completes a phase II trial in Liver cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Spain, South Korea, Italy, Japan, Israel, Germany, USA (PO) (NCT04696055) (EudraCT2020-003555-16)

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