Drug · Small Molecule

Cabazitaxel

CI-DRUG-00000130Explore in graph →NCIt C66937 CHEMBL1201748 CIViC Approved

Regulatory

Approvals (13)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2020-12-18 (see label)	approved	Dec 18, 2020	openfda
US FDA	—	Efficacy supplement 2017-09-14 (see label)	approved	Sep 14, 2017	openfda
US FDA	—	Efficacy supplement 2017-05-17 (see label)	approved	May 17, 2017	openfda
US FDA	Castration-Resistant Prostate Carcinoma	JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. ( 1 )

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 15 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	19	9	17	102	13	CA, EU, US	Jun 17, 2010	1999-10
Malignant Prostate Neoplasm	Approved	Phase 4	15	6	10	45	3	EU, US	Jun 17, 2010	2011-01
Malignant Bladder Neoplasm	Phase2	Phase 2	1	0	0	1	0	—	—	Dec 1, 2014
Malignant Breast Neoplasm	Phase2	Phase 2	0	0	0	4	0

Curated evidence

Clinical evidence (3)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
AR AR-V71
Cabazitaxel	Malignant Prostate Neoplasm

Clinical trials

Trials with this intervention (104)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 104 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02379390	Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide(PRIMCAB)	terminated	Phase 2	8	SanofiINDUSTRY	2	Jun 21, 2019	clinicaltrials
NCT01308567	Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: Tubulin inhibitor
Targets: 15 genes
Aliases: 1-hydroxy-7beta,10beta-dimethoxy-9-oxo-5beta,20-epoxytax-11-ene-2alpha,4,13alpha-triyl 4-acetate 2-benzoate 13-[(2R,3S)-3-{[(tertbutoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoate], Cabazitaxel, Cabazitaxel accord, Cabazitaxel acetonate, Jevtana, JEVTANA, Jevtana kit, NSC-761432, RPR 116258A, RPR116258A, Taxoid XRP6258, TXD 258, TXD258, XRP 6258, XRP6258

Data updated 18 hours agoSource updated unknown

Identifiers

Codes (18)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01CD	Antineoplastic agents
ATC (WHO)	L01CD04	CABAZITAXEL
DIN (Health Canada)

IGF2 Overexpression2
Cabazitaxel + LinsitinibCombination	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	3	submitted	EID12428 OSI-906, an IGF1R/INSR inhibitor, sensitizes cell lines to cabazitaxel, resulting in better overall survival in mouse xenografts of patient derived chemotherapy resistant castration-resistant prostate… (full text at CIViC) PMID 25670080 · Vidal et al., 2015 · Open in CIViC	civic
Cabazitaxel + Docetaxel + LinsitinibSubstitutes	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID414 OSI-906, an IGF1R/INSR inhibitor, sensitizes cell lines to docetaxel and cabazitaxel, resulting in better overall survival in mouse xenografts of patient derived chemotherapy resistant castration-resi… (full text at CIViC) PMID 25670080 · Vidal et al., 2015 · Open in CIViC	civic