Cabazitaxel

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.

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
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer	2024/12/17	NCT06738303	Phase 2	Recruiting	Case Comprehensive Cancer Center
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)	2024/11/18	NCT06691984	Phase 3	Recruiting	Amgen
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial	2024/10/09	NCT06632977	Phase 2	Recruiting	Alliance for Clinical Trials in Oncology
Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body	2024/06/24	NCT06470243	Phase 3	Recruiting	SWOG Cancer Research Network
Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)	2024/04/09	NCT06353386	Phase 1	Recruiting	Merck Sharp & Dohme LLC
Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)	2023/10/17	NCT06085729	Phase 1	Recruiting	M.D. Anderson Cancer Center
A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer	2023/04/19	NCT05818683	Phase 1	Recruiting	Janssen Research & Development, LLC
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland	2023/01/26	NCT05701007	N/A	Completed	Pfizer
Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)	2022/10/03	NCT05563558	Phase 2	Recruiting	Fundacion Oncosur
Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer	2022/04/22	NCT05340374	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
Jevtana	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE	Authorised	3/17/2011
Cabazitaxel Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	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	Sanofi-Aventis Deutschland GmbH (Drug Product & Solvent)	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	Dr Reddys Laboratories Australia Pty Ltd	Medicine	A	7/23/2018
CABAZITAXEL DR.REDDY'S cabazitaxel 60 mg/1.5 mL concentrated injection vial	287928	Dr Reddys Laboratories Australia Pty Ltd	Medicine	A	7/23/2018
CABAZITAXEL EVER PHARMA cabazitaxel 50 mg/5 mL concentrated solution for injection vial	320982	Interpharma Pty Ltd	Medicine	A	10/27/2020
MSN CABAZITAXEL cabazitaxel 60 mg/1.5 mL concentrated injection vial and diluent vial	316240	Reach Pharmaceuticals Pty Ltd	Medicine	A	8/26/2020
CABAZITAXEL ACCORD cabazitaxel 60 mg/3 mL concentrated injection vial	340843	Accord Healthcare Pty Ltd	Medicine	A	8/3/2021
CABAZITAXEL INTAS cabazitaxel 60 mg/3 mL concentrated injection vial	340842	Accord Healthcare Pty Ltd	Medicine	A	8/3/2021
CABAZITAXEL EVER PHARMA cabazitaxel 60 mg/6 mL concentrated solution for injection vial	321013	Interpharma Pty Ltd	Medicine	A	10/27/2020
CABAZITAXEL-REDDY'S cabazitaxel 60 mg/1.5 mL concentrated injection vial	287930	Dr Reddys Laboratories Australia Pty Ltd	Medicine	A	7/23/2018
CABAZITAXEL EVER PHARMA cabazitaxel 45 mg/4.5 mL concentrated solution for injection vial	320981	Interpharma Pty Ltd	Medicine	A	10/27/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
JEVTANA	sanofi-aventis canada inc	02369524	Solution - Intravenous	40 MG / ML	8/23/2011
CABAZITAXEL FOR INJECTION	Sandoz Canada, Inc.	02487497	Solution - Intravenous	45 MG / 4.5 ML	12/18/2019
CABAZITAXEL FOR INJECTION	dr reddy's laboratories ltd	02495635	Solution - Intravenous	40 MG / ML	6/1/2020
CABAZITAXEL FOR INJECTION	marcan pharmaceuticals inc	02503581	Solution , Kit - Intravenous	40 MG / ML	N/A
CABAZITAXEL FOR INJECTION	formative pharma inc.	02553783	Solution - Intravenous	45 MG / 4.5 ML	4/10/2025
CABAZITAXEL FOR INJECTION	Sandoz Canada, Inc.	02487500	Solution - Intravenous	60 MG / 6 ML	12/18/2019
CABAZITAXEL FOR INJECTION	formative pharma inc.	02553791	Solution - Intravenous	60 MG / 6 ML	4/10/2025

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CABAZITAXEL VIVANTA 60 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG	Vivanta Generics S.R.O.	88000	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CABAZITAXEL FRESENIUS KABI 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Fresenius Kabi España, S.A.U.	88251	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CABAZITAXEL DR. REDDYS 60 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG	Reddy Pharma Iberia S.A.	85227	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CABAZITAXEL MYLAN 60 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG	Mylan Pharmaceuticals S.L.	85660	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CABAZITAXEL ACCORD 20 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION	Accord Healthcare S.L.U.	1201448001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
JEVTANA 60 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION	Sanofi Winthrop Industrie	11676001	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
JEVTANA 60 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION	Sanofi-Aventis Groupe	11676001IP	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
CABAZITAXEL ZENTIVA 60 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG	Zentiva K.S.	85908	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CABAZITAXEL AUROVIT 20 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Eugia Pharma (Malta) Limited	88361	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CABAZITAXEL SANDOZ 10MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Sandoz Farmaceutica S.A.	86036	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not 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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