NDAINTRAVENOUSSOLUTION
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
CABAZITAXEL (cabazitaxel) by Teva is inhibitor. Approved for combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. First approved in 2024.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cabazitaxel is a microtubule-stabilizing chemotherapy agent administered intravenously in combination with prednisone. It is indicated for metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with docetaxel-containing regimens. The drug binds to tubulin and promotes microtubule assembly while inhibiting disassembly, thereby disrupting cellular mitosis and interphase functions.
Growth
Teva's recently approved growth-stage asset in a specialized oncology segment with moderate competitive pressure presents mid-career opportunities in launch execution and market penetration.
Mechanism of Action
inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions.
Clinical Trials (20)
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
Started Dec 2024
707 enrolled
Metastatic Castration-resistant Prostate Cancer
Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer
Started Dec 2020
120 enrolled
Aggressive Variant Prostate CarcinomaCastration-Resistant Prostate CarcinomaMetastatic Prostate Carcinoma+3 more
A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
Started Aug 2020
30 enrolled
Progressive Metastatic Castrate-Resistant Prostate Cancer
Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide
Started Apr 2019
57 enrolled
Metastatic Prostate Cancer
Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Started Dec 2017
2 enrolled
Hormone-Resistant Prostate CancerStage IV Prostate Adenocarcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.