Overview
Vandetanib is an oral once-daily kinase inhibitor of tumour angiogenesis and tumour cell proliferation with the potential for use in a broad range of tumour types. On April 6 2011, vandetanib was approved by the FDA to treat nonresectable, locally advanced, or metastatic medullary thyroid cancer in adult patients.
Indication
Vandetanib is currently approved as an alternative to local therapies for both unresectable and disseminated disease. Because Vandetanib can prolong the Q-T interval, it is contraindicated for use in patients with serious cardiac complications such as congenital long QT syndrome and uncompensated heart failure.
Associated Conditions
- Metastatic Thyroid Gland Medullary Carcinoma
- Locally advanced Medullary thyroid cancer
Research Report
A Comprehensive Monograph on Vandetanib (Caprelsa)
This report has been compiled by a PhD researcher specializing in the authoring of technical papers and clinical pharmacology reviews. The content is intended for an audience of clinical oncologists, pharmacologists, regulatory affairs specialists, and other healthcare professionals with advanced knowledge in oncology and drug development.
1.0 Executive Summary
Vandetanib is an orally administered, once-daily, small-molecule antineoplastic agent that represents a significant therapeutic advance in the management of a rare and aggressive malignancy. It is classified as a multi-targeted tyrosine kinase inhibitor (TKI), a pharmacological class of drugs designed to interfere with specific cellular signaling pathways that drive cancer growth and survival. The core mechanism of action of Vandetanib is distinguished by its simultaneous inhibition of three key receptor tyrosine kinases: the Vascular Endothelial Growth Factor Receptor (VEGFR), the Epidermal Growth Factor Receptor (EGFR), and the REarranged during Transfection (RET) proto-oncogene.[1] This tripartite blockade provides a dual-pronged attack on tumors, directly inhibiting cancer cell proliferation and survival while concurrently disrupting the tumor's ability to form new blood vessels (angiogenesis), a process essential for its growth and metastasis.
The primary clinical indication for Vandetanib is the treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.[4] This approval was based on the pivotal results of the Phase III ZETA trial, which demonstrated a statistically significant and clinically meaningful improvement in Progression-Free Survival (PFS) for patients treated with Vandetanib compared to those receiving placebo.[6] This established Vandetanib as the first therapeutic agent specifically approved for this challenging indication.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/01 | Phase 2 | Recruiting | |||
2021/02/18 | Phase 3 | Withdrawn | |||
2019/12/26 | Phase 3 | Active, not recruiting | |||
2018/08/14 | Phase 2 | Terminated | |||
2017/09/25 | Early Phase 1 | Completed | |||
2015/12/23 | Phase 2 | UNKNOWN | |||
2015/08/21 | Phase 2 | UNKNOWN | Velindre NHS Trust | ||
2015/07/13 | Phase 1 | Terminated | |||
2014/11/24 | Phase 2 | Active, not recruiting | |||
2014/09/15 | Not Applicable | UNKNOWN | Amsterdam UMC, location VUmc |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genzyme Corporation | 58468-7820 | ORAL | 100 mg in 1 1 | 3/15/2024 | |
| Genzyme Corporation | 58468-7840 | ORAL | 300 mg in 1 1 | 3/15/2024 | |
| Genzyme Corporation | 58468-7860 | ORAL | 300 mg in 1 1 | 8/19/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/16/2012 | ||
Authorised | 2/16/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CAPRELSA vandetanib 100mg film coated tablet blister pack | 192496 | Medicine | A | 1/31/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CAPRELSA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 11749001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| CAPRELSA 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 11749002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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