Overview
Cabozantinib was first approved in 2012 and is a non-specific tyrosine kinase inhibitor. It was initially approved in the US under the brand name Cometriq, which is indicated for the treatment of metastatic medullary thyroid cancer. In 2016, a capsule formulation (Cabometyx) was approved for the treatment of advanced renal cell carcinoma, and this same formulation gained additional approval in both the US and Canada in 2019 for the treatment of hepatocellular carcinoma in previously treated patients.
Indication
⑴治疗进展的、不能切除的局部晚期或转移的髓性甲状腺癌。 ⑵用于舒尼替尼（索坦）治疗失败的晚期肾癌。
Associated Conditions
- Advanced Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Metastatic Differentiated Thyroid Cancer
- Locally advanced Differentiated Thyroid Cancer (DTC)
- Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
- Progressive, metastatic Medullary thyroid cancer
Research Report
Cabozantinib (DB08875): A Comprehensive Monograph on its Pharmacology, Clinical Development, and Therapeutic Role
Section 1: Executive Summary and Drug Profile
1.1. Overview of Cabozantinib as a Multi-Targeted Tyrosine Kinase Inhibitor
Cabozantinib is an orally bioavailable small molecule that represents a significant therapeutic advance in the field of oncology. It functions as a potent, non-specific inhibitor of multiple receptor tyrosine kinases (RTKs), which are key mediators of cellular signaling pathways that drive cancer progression.[1] The fundamental mechanism of action of cabozantinib involves the simultaneous suppression of critical processes including tumor growth (oncogenesis), the formation of new tumor-supplying blood vessels (angiogenesis), and the spread of cancer to distant sites (metastasis).[1] This broad-spectrum activity against the core drivers of malignancy underpins its demonstrated efficacy across a diverse and expanding range of solid tumors, establishing it as a versatile and powerful agent in the modern anticancer armamentarium.
1.2. Key Identifiers, Formulations, and Brand Names (Cometriq® vs. Cabometyx®)
The drug is identified by its DrugBank ID DB08875 and Chemical Abstracts Service (CAS) Number 849217-68-1. During its development, it was also known by the codes XL184 and BMS-907351.[1] A crucial aspect of cabozantinib's clinical and commercial profile is the existence of two distinct brand names, which correspond to different formulations, approved dosages, and initial therapeutic indications.[8] Understanding this distinction is fundamental to appreciating its development history and appropriate clinical use.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/18 | Phase 2 | UNKNOWN | University of Bologna | ||
2019/10/04 | Phase 2 | Recruiting | |||
2019/09/17 | Phase 2 | Active, not recruiting | |||
2019/09/06 | Phase 2 | Active, not recruiting | |||
2019/08/28 | Phase 2 | Recruiting | |||
2019/08/26 | Phase 2 | Terminated | Johannes Gutenberg University Mainz | ||
2019/07/17 | Phase 2 | Active, not recruiting | |||
2019/05/30 | Phase 2 | Completed | |||
2019/05/28 | Phase 2 | Terminated | |||
2019/05/24 | Phase 4 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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