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
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2021/02/18 | Phase 3 | Withdrawn | |||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 |
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