JEVTANA KIT (cabazitaxel)
Jevtana is used for patients with advanced prostate cancer that has spread to other parts of the body and no longer responds to hormone-lowering therapies. It is prescribed alongside prednisone for individuals who have already undergone a treatment regimen containing docetaxel. This medication helps patients manage metastatic castration-resistant prostate cancer after other specific chemotherapy options have been used.
How JEVTANA KIT Works
This drug works by binding to tubulin, a protein that helps cells maintain their structure and divide. It promotes the assembly of microtubules while preventing them from breaking down, which stabilizes these structures and interferes with vital cellular functions. This process effectively inhibits the ability of cancer cells to multiply and grow.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-06-17
- Patent Cliff
- 2031
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
JEVTANA KIT Approval History
What JEVTANA KIT Treats
1 indicationsJEVTANA KIT is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
JEVTANA KIT Boxed Warning
NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 ( 4 ,...
WARNING: NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 ( 4 , 5.1 , 5.2 ) Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy. ( 2.1 , 5.2 ) Contraindicated if history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80. ( 4 ) Neutropenia : Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 [see Contraindications (4) and Warnings and Precautions (5.1 , 5.2) ] . Severe hypersensitivity : Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.3) ] .
JEVTANA KIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JEVTANA KIT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JEVTANA KIT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to JEVTANA KIT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
67 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07213674 | 20230239 | Ph 3 | recruiting | A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer |
| NCT06632977 PREDICT | A032102 NCI-2024-04960 | Ph 2 | recruiting | Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial |
| NCT05818683 | CR109321 78278343PCR1003, 2022-503132-14-00 | Ph 1 | recruiting | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer |
| NCT06353386 | 5684-01A MK-5684-01A, 2023-506288-33-00 | Ph 1, Ph 2 | recruiting | 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) |
| NCT04709276 CHAMP | Pro00106278 CA209-63X | Ph 2 | active not recruiting | A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer |
| NCT02115165 CABA-GCT | 2013-000286-36 2012/1950 | Ph 2 | completed | A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors |
| NCT06085729 | 2023-0467 NCI-2023-08684 | Ph 1, Ph 2 | recruiting | Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC) |
| NCT03419234 results posted | EA8153 NCI-2017-00389, EA8153 | Ph 2 | active not recruiting | Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel |
| NCT06691984 | 20230005 2024-513968-25 | Ph 3 | active not recruiting | Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) |
| NCT02703623 | 2014-0386 NCI-2016-00670, 2014-0386 | Ph 2 | active not recruiting | Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer |
| NCT02522715 results posted | IRB00011227 NCI-2015-01103, 11227 | Ph 1, Ph 2 | active not recruiting | Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer |
| NCT03263650 | 2017-0133 NCI-2018-01071, 2017-0133 | Ph 2 | active not recruiting | Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC |
| NCT06470243 | S2312 NCI-2024-04336, S2312 | Ph 3 | recruiting | 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 |
| NCT04592237 | 2020-0200 NCI-2020-07731, 2020-0200 | Ph 2 | active not recruiting | Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer |
| NCT02985957 CheckMate 650 results posted | CA209-650 2016-001928-54 | Ph 2 | completed | A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650) |
| NCT01952223 PEACE2 | GETUG-AFU 23 - UC-0160/1202 2012-000566-38 | Ph 3 | active not recruiting | A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse |
| NCT01420250 | 11D.243 2011-32, JT 1820 | Ph 1 | completed | Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer |
| NCT01437488 results posted | 11D.392 2011-52, JT 2205 | Ph 2 | completed | Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy |
| NCT05340374 LuCAB | 21/018 | Ph 1, Ph 2 | active not recruiting | Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer |
| NCT02202772 CGC | AAAM8506 | Ph 1, Ph 2 | active not recruiting | Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder |
| NCT05563558 PEAPOD_FOS | PEAPOD_FOS04/2022 | Ph 2 | recruiting | Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS) |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT03934840 | 2018LS158 c17-191 | Ph 2 | active not recruiting | CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone |
| NCT02903160 results posted | GCO 16-1593 CABAZL07459, ONC-2014-168 | Ph 2 | completed | Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC) |
| NCT02478502 | 2012/1627 b 2012-004418-32 | Ph 2 | terminated | Testis CAB: Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell Cancer |
| NCT04495179 AARDVARC results posted | D8731C00002 2020-000209-10 | Ph 2 | completed | A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. |
| NCT03114254 JAVA-P | ON/2012/4233 2014-002336-14, CabazL05881 | Ph 2 | completed | A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis |
| NCT03392428 TheraP | ANZUP 1603 | Ph 2 | completed | A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer |
| NCT02961257 CABASTY | CABASTY | Ph 3 | completed | Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel |
| NCT03295565 OSTRICh | m16OST | Ph 2, Ph 3 | completed | Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel |
| NCT01650285 results posted | BrUOG 246 | Ph 2 | terminated | Cabazitaxel and Radiation For Patients With Prostate Cancer |
| NCT03101046 TACTIK | GETUG-AFU-28 - UC-0160/1613 2016-002429-12 | Ph 2 | completed | Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic |
| NCT01913652 | EORTC-1202 2012-003672-39, cabazL06470 | Ph 2 | completed | Ph II Cabazitaxel DD Liposarcoma |
| NCT01505868 results posted | 2011-0727 NCI-2012-00059, 2011-0727 | Ph 1, Ph 2 | completed | Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer |
| NCT01620242 ORL03 | UC-0130/1106 2011-004712-32 | Ph 2 | completed | A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes |
| NCT02844582 results posted | 868922 UCDCC#261, UCDCC#261 | Ph 2 | terminated | Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer |
| NCT02560337 CaTo-ROC | CaTo-ROC | Ph 2 | completed | Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy. |
| NCT03043989 | J16144 IRB00117591 | Ph 1 | terminated | Cohorts of Docetaxel or Cabazitaxel in Combination With the Potent CYP3A4 Inhibitor, Clarithromycin |
| NCT02512458 CABA-BONE | HE 9A/14 2014-004485-21 | Ph 2 | completed | Study of the Effect of Chemotherapy With Cabazitaxel on Prostate Cancer |
| NCT01668459 CabB1 | RRK4368 2012-002552-16 | Ph 2, Ph 3 | completed | Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel |
| NCT01845792 results posted | 13-1489.cc NCI-2013-01356 | Ph 2 | terminated | Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer |
| NCT01956149 | CabaGast | Ph 2 | completed | Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer |
| NCT01757171 results posted | 1208012946 | Ph 2 | completed | Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma |
| NCT02166658 CaBaMet | AIO-ZNS-0113 2013-005545-37, CABAZL06457 | Ph 2 | terminated | A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet) |
| NCT01740570 | 2012-0228 | Ph 1, Ph 2 | withdrawn | Phase I/II Cabazitaxel for Recurrent Malignant Glioma |
| NCT01866449 | C-GBM (XRP6258) | Ph 2 | completed | Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme |
| NCT01693549 | HE 11B/11 2011-003625-97 | Ph 2 | completed | Study of Cabazitaxel in Patients With Metastatic Breast Cancer Previously Treated With Taxanes |
| NCT01594918 | UCSF Protocol No. 11951 | Ph 1 | completed | Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer |
| NCT01934894 results posted | SCRI BRE 200 | Ph 2 | terminated | Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases |
| NCT01528163 RACATREX | UCL-ONCO 2011-01 2011-001938-42 | Ph 2 | completed | Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
Showing 50 of 67 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JEVTANA KIT FDA Label Details
Indications & Usage
FDA Label (PDF)JEVTANA KIT is indicated for the treatment of Prostate Cancer.
WARNING: NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil coun...
JEVTANA KIT Patents & Exclusivity
Patents (10 active)
Pro Intelligence Preview
Deep insights for JEVTANA KIT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 10 active patents
Trial Analysis
- • 68 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment