Overview
Cabazitaxel is a taxoid synthesized from 10-deacetylbaccatin III, a compound isolated from the yew tree. As a second-generation semisynthetic microtubule inhibitor, cabazitaxel stabilizes microtubules and induces tumour cell death. Due to its low affinity for the P-glycoprotein (P-gp) efflux pump, cabazitaxel can more readily penetrate the blood–brain barrier compared to other taxanes like paclitaxel and docetaxel. Cabazitaxel is used to treat metastatic castration-resistant prostate cancer. It was first approved by the FDA on June 17, 2010. It was also approved by the EMA on March 17, 2011 and Health Canada on December 17, 2019.
Background
Cabazitaxel is a taxoid synthesized from 10-deacetylbaccatin III, a compound isolated from the yew tree. As a second-generation semisynthetic microtubule inhibitor, cabazitaxel stabilizes microtubules and induces tumour cell death. Due to its low affinity for the P-glycoprotein (P-gp) efflux pump, cabazitaxel can more readily penetrate the blood–brain barrier compared to other taxanes like paclitaxel and docetaxel. Cabazitaxel is used to treat metastatic castration-resistant prostate cancer. It was first approved by the FDA on June 17, 2010. It was also approved by the EMA on March 17, 2011 and Health Canada on December 17, 2019.
Indication
用于治疗转移性去势抵抗性前列腺癌患者。
Associated Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/17 | Phase 2 | Not yet recruiting | |||
2024/11/18 | Phase 3 | Recruiting | |||
2024/10/09 | Phase 2 | Recruiting | |||
2024/06/24 | Phase 3 | Recruiting | |||
2024/04/09 | Phase 1 | Recruiting | |||
2023/10/17 | Phase 1 | Recruiting | |||
2023/04/19 | Phase 1 | Recruiting | |||
2023/01/26 | N/A | Completed | |||
2022/10/03 | Phase 2 | Recruiting | |||
2022/04/22 | Phase 1 | Active, not recruiting | Peter MacCallum Cancer Centre, Australia |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/28/2020 | ||
Authorised | 8/28/2020 | ||
Authorised | 3/17/2011 | ||
Authorised | 3/17/2011 | ||
Authorised | 8/28/2020 | ||
Authorised | 8/28/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Jevtana® Concentrate and Solvent for Solution for Infusion 60mg/1.5ml | SIN14043P | INFUSION, SOLUTION CONCENTRATE | 60mg/1.5ml | 11/2/2011 |
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 |
|---|---|---|---|---|---|
| CABAZITAXEL-DRLA cabazitaxel 60 mg/1.5 mL concentrated injection vial | 287927 | Medicine | A | 7/23/2018 | |
| CABAZITAXEL DR.REDDY'S cabazitaxel 60 mg/1.5 mL concentrated injection vial | 287928 | Medicine | A | 7/23/2018 | |
| CABAZITAXEL EVER PHARMA cabazitaxel 50 mg/5 mL concentrated solution for injection vial | 320982 | Medicine | A | 10/27/2020 | |
| MSN CABAZITAXEL cabazitaxel 60 mg/1.5 mL concentrated injection vial and diluent vial | 316240 | Medicine | A | 8/26/2020 | |
| CABAZITAXEL ACCORD cabazitaxel 60 mg/3 mL concentrated injection vial | 340843 | Medicine | A | 8/3/2021 | |
| CABAZITAXEL INTAS cabazitaxel 60 mg/3 mL concentrated injection vial | 340842 | Medicine | A | 8/3/2021 | |
| CABAZITAXEL EVER PHARMA cabazitaxel 60 mg/6 mL concentrated solution for injection vial | 321013 | Medicine | A | 10/27/2020 | |
| CABAZITAXEL-REDDY'S cabazitaxel 60 mg/1.5 mL concentrated injection vial | 287930 | Medicine | A | 7/23/2018 | |
| CABAZITAXEL EVER PHARMA cabazitaxel 45 mg/4.5 mL concentrated solution for injection vial | 320981 | Medicine | A | 10/27/2020 |