Drug Profile

Cabozantinib - Exelixis/Ipsen

Alternative Names: BMS-907351; CABOMETYX; Cabometyx; Cabozantinib s-malate; Cometriq; XL-184

Latest Information Update: 24 Jun 2025

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At a glance

Originator Exelixis
Developer Bristol-Myers Squibb; Centre Francois Baclesse; Dana-Farber Cancer Institute; Duke University Medical Center; Emory University; Exelixis; Ipsen; Massachusetts General Hospital; Memorial Sloan-Kettering Cancer Center; Merck Sharp & Dohme; National Cancer Institute (USA); Roche; Swedish Orphan Biovitrum; Takeda; University of California at Irvine; University of Kentucky
Class Amides; Anilides; Antineoplastics; Cyclopropanes; Fluorine compounds; Quinolines; Small molecules
Mechanism of Action Axl receptor tyrosine kinase inhibitors; Fms-like tyrosine kinase 3 inhibitors; Proto-oncogene protein c-met inhibitors; Proto-oncogene protein c-ret inhibitors; TIE-2 receptor antagonists; TrkB 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 - Neuroendocrine tumours; Thyroid cancer; Liver cancer
New Molecular Entity Yes

Marketed Liver cancer; Renal cell carcinoma; Thyroid cancer
Registered Neuroendocrine tumours
Phase III Non-small cell lung cancer; Prostate cancer
Phase II Adenocarcinoma; Adrenocortical carcinoma; Bone metastases; Brain metastases; Breast cancer; Cervical cancer; Cholangiocarcinoma; Endometrial cancer; Ewing's sarcoma; Fallopian tube cancer; Gastrointestinal cancer; Head and neck cancer; Malignant fibrous histiocytoma; Malignant melanoma; Merkel cell carcinoma; Osteosarcoma; Ovarian cancer; Peritoneal cancer; Phaeochromocytoma; Urogenital cancer; Uveal melanoma
Phase I/II Multiple myeloma; Solid tumours
No development reported Acute myeloid leukaemia; Astrocytoma; Cancer; Colorectal cancer; Glioblastoma

20 Jun 2025 The Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion for cabozantinib in Neuroendocrine tumours (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in European Union (PO)
26 Mar 2025 Registered for Neuroendocrine tumours (Late-stage disease, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater, In adults, In the elderly, In adolescents) in USA (PO)
15 Feb 2025 Efficacy and adverse event data from the phase III CheckMate 9ER trial in Renal cell carcinoma released by Exelixis

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