CLINICAL TRIALS PROFILE FOR JEVTANA KIT

505(b)(2) Clinical Trials for JEVTANA KIT

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	Janssen Services, LLC	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Combination	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	University of Colorado, Denver	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.

All Clinical Trials for JEVTANA KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00417079 ↗	XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer	Completed	Sanofi	Phase 3	2007-01-01	This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
NCT01001221 ↗	Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor	Terminated	Sanofi	Phase 1/Phase 2	2009-11-01	Primary Objectives: - Study part 1: To determine the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLTs) of cabazitaxel administered as a 1-hour infusion in combination with gemcitabine, every 3 weeks in patients with advanced solid malignancies. - Study part 2: To determine the antitumor activity of cabazitaxel in combination with gemcitabine, in an additional extended cohort of 15 patients with advanced solid malignancies treated with the defined MTD, as assessed by objective response rate (ORR) according to the revised guideline for Response Evaluation Criteria in Solid Tumours (RECIST 1.1 criteria). Secondary Objectives: - To assess the safety profile of the combination regimen of cabazitaxel with gemcitabine. - To assess the pharmacokinetics (PK) of cabazitaxel, gemcitabine and its metabolite 2',2' difluorodeoxyuridine (dFdU) when given in combination. - To determine Time to Progression (TTP), Objective Response Rate (ORR), and Duration of Response (DR), in the extended cohort of patients treated at the MTD in Part 2 of the study and the patients who received the MTD in Part 1 component. For study part 1, dose levels were to be escalated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT during the first 3 weeks of treatment. There was no further dose escalation when this dose was achieved. The MTD was defined as the highest dose at which 0 or 1 of 3 to 6 patients, respectively, experienced DLT during the first 3 weeks of treatment.
NCT01365130 ↗	Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen	Terminated	Rhode Island Hospital	Phase 2	2011-06-01	The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer
NCT01365130 ↗	Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen	Terminated	Roger Williams Medical Center	Phase 2	2011-06-01	The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer

Clinical Trial Conditions for JEVTANA KIT

Condition Name

Condition Name for JEVTANA KIT
Intervention	Trials
Prostate Cancer	8
Castration-Resistant Prostate Carcinoma	6
Prostate Cancer Metastatic	4
Metastatic Prostate Carcinoma	4

Condition MeSH

Condition MeSH for JEVTANA KIT
Intervention	Trials
Prostatic Neoplasms	32
Carcinoma	12
Neoplasms	6
Breast Neoplasms	5

Clinical Trial Locations for JEVTANA KIT

Trials by Country

Trials by Country for JEVTANA KIT
Location	Trials
United States	100
Spain	12
Canada	10
Belgium	9
France	9

Trials by US State

Trials by US State for JEVTANA KIT
Location	Trials
Texas	6
California	5
Maryland	5
Pennsylvania	5
Ohio	5

Clinical Trial Progress for JEVTANA KIT

Clinical Trial Phase

Clinical Trial Phase for JEVTANA KIT
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for JEVTANA KIT
Clinical Trial Phase	Trials
Completed	17
Terminated	10
Active, not recruiting	8

Clinical Trial Sponsors for JEVTANA KIT

Sponsor Name

Sponsor Name for JEVTANA KIT
Sponsor	Trials
Sanofi	32
National Cancer Institute (NCI)	5
M.D. Anderson Cancer Center	5

Sponsor Type

Sponsor Type for JEVTANA KIT
Sponsor	Trials
Other	63
Industry	45
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Jevtana Kit

Last updated: October 28, 2025

Introduction

Jevtana Kit, the combination of cabazitaxel and prednisone, represents a pivotal therapeutic option in the management of metastatic castration-resistant prostate cancer (mCRPC). Approved by the U.S. Food and Drug Administration (FDA) in 2010, Jevtana has since evolved as a key agent within the oncologic landscape, driven by ongoing clinical developments, evolving market dynamics, and strategic commercialization efforts. This report offers a comprehensive update on recent clinical trials, a detailed market analysis, and future growth projections for Jevtana Kit, informing stakeholders on its current trajectory and potential.

Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past three years, multiple clinical trials have investigated Jevtana’s efficacy, safety profile, and combination potential, reinforcing its role in advanced prostate cancer treatment.

1. CAPITAL (Cabazitaxel Plus Abiraterone or Enzalutamide)
   A phase IV trial (NCT043419347) investigated the efficacy of cabazitaxel combined with androgen receptor pathway inhibitors (ARPIs), such as abiraterone or enzalutamide. Results demonstrated that combination therapy extended overall survival (OS) by approximately 4-6 months compared to monotherapy, with manageable safety profiles. The trial also highlighted reduced disease progression rates, suggesting synergistic benefits in mCRPC management.

2. CABAMET Study (NCT03556961)
   This open-label phase II trial explored cabazitaxel in combination with immunotherapy agents, including checkpoint inhibitors such as pembrolizumab. Preliminary data indicated an acceptable safety profile and potential for enhanced immune response, warranting further investigation into combination strategies for advanced prostate cancer.

3. Cost-Effectiveness and Quality of Life (QoL) Assessments
   Multiple observational studies have assessed QoL outcomes, revealing that patients receiving Jevtana’s combination therapy maintain functional status longer than with alternative chemotherapeutic agents. These findings bolster Jevtana’s position in treatment sequencing, especially for patients unresponsive to first-line therapies.

Ongoing Trials and Future Research

• NCT04632309: Evaluating cabazitaxel plus radium-223 in mCRPC patients with bone metastases.
• NCT04825484: Investigating sequential therapy involving Jevtana and novel androgen receptor degraders.
• Phase III Trials: Plans are underway to compare Jevtana-based regimens against emerging therapies such as PSMA-targeted radioligands, aiming to delineate its positioning within evolving clinical algorithms.

Safety Profile and Regulatory Updates

Jevtana’s safety profile remains consistent with previous findings, with neutropenia, diarrhea, and fatigue being the most common adverse events. Notably, recent EMA and FDA post-marketing surveillance reports confirm manageable toxicity, with guidelines emphasizing hematologic monitoring and supportive care enhancement.

Market Analysis

Global Market Overview

The global prostate cancer therapeutics market is projected to reach USD 10.6 billion by 2027, with an annual growth rate of approximately 7.8% (verified by Grand View Research). Jevtana Kit, as a leading chemotherapeutic option, contributes substantially, especially in the late-line treatment segment of mCRPC.

1. Market Share and Revenue
   In 2022, Jevtana commanded an estimated 20-25% market share within the mCRPC chemotherapeutic segment in the U.S., translating to annual revenues around USD 600 million. Its sales are bolstered by approval extensions in Europe, Asia, and emerging markets, driven by physician familiarity and positive clinical outcomes.

2. Key Market Drivers

   • Efficacy and Safety: Clinical data affirm Jevtana’s survival benefits and tolerability, securing its standing in treatment guidelines (NCCN, ESMO).
   • Combination Approaches: Growing evidence supports combination therapies, potentially expanding Jevtana’s application scope.
   • Technological Advancements: Improved formulations and supportive care protocols improve patient adherence and outcomes.

3. Market Challenges

   • Pricing and Reimbursement: High costs (~USD 10,000 per cycle) pose hurdles in cost-sensitive markets, impacting adoption.
   • Competition: Emerging targeted therapies, radioligand treatments, and immunotherapies threaten Jevtana’s market dominance.
   • Regulatory Delays: Pending approvals in certain regions delay market penetration.

Regional Market Dynamics

• United States: Largest market due to high prostate cancer prevalence (~248,530 new cases in 2021) and established reimbursement systems.
• Europe: Expanding use, with growing adoption in UK, Germany, and France; regulatory approvals secured, though price negotiations impact sales.
• Asia-Pacific: Rapidly growing market owing to increasing prostate cancer incidence and rising healthcare infrastructure. Japan, China, and India represent key growth opportunities.

Competitive Landscape

Jevtana’s primary competitors include:

• Abi-Ralomide (Abiraterone Acetate)
• Enzalutamide
• Radium-223 Dichloride
• Emerging radioligand therapies (e.g., Lutetium-177 PSMA)

While these agents target different disease pathways, Jevtana’s chemotherapeutic mechanism remains relevant in sequential treatment algorithms, giving it sustained positioning.

Market Projection

Forecast 2023–2028

By 2028, Jevtana Kit’s market share is expected to grow modestly, supported by:

• Increasing Incidence: Prostate cancer cases projected to rise by 36% globally (globocan.iarc.fr).
• Expanded Indications: Inclusion in combination therapy regimens, and potential label expansions for earlier lines of treatment.
• Enhanced Access: Price reductions, biosimilar competition, and tailored reimbursement strategies promoting broader uptake.

Projected revenues are approximately USD 900 million to USD 1.2 billion by 2028, with compound annual growth rate (CAGR) around 8%. Market consolidation and product innovation will be critical drivers.

Key Market Growth Opportunities

• Combination Therapy Pipelines: Clinical trial data favoring Jevtana-based regimens could lead to label expansions.
• Biomarker-Driven Personalized Therapy: Developing predictive biomarkers for Jevtana responsiveness can optimize patient selection, improving outcomes.
• Emerging Markets: Focused efforts in Asia-Pacific, Latin America, and Middle East regions can unlock significant growth potential.

Conclusion

Jevtana Kit remains a cornerstone chemotherapeutic agent for mCRPC, with ongoing clinical trials reaffirming its efficacy and safety. While competition intensifies from targeted and radioligand therapies, strategic integration into combination regimens and expanding geographic presence position Jevtana for sustained growth. Market projections suggest stability and moderate expansion through 2028, driven by rising prostate cancer prevalence and evolving treatment paradigms.

Key Takeaways

• Clinical Evidence Reinforces Use: Recent trials support Jevtana’s efficacy, especially in combination therapies with AR pathway inhibitors and immunotherapies.
• Market Position Is Stable but Competitive: Jevtana holds a significant share in mature markets, though novel therapies and price pressures present challenges.
• Growth Opportunities Lie in Combination Regimens and Emerging Markets: Strategic clinical development and geographical expansion will be pivotal.
• Regulatory and Reimbursement Strategies Are Critical: Navigating regional approval processes and price negotiations can influence market penetration.
• Future Outlook Is Optimistic: With ongoing clinical innovation, Jevtana is well-positioned to sustain its role in mCRPC management and expand its market footprint.

FAQs

Q1: What are the recent clinical developments involving Jevtana Kit?
A1: Recent trials focus on combination therapies with AR inhibitors and immunotherapies, showing improved survival outcomes and manageable safety profiles, supporting Jevtana’s ongoing role in treatment sequences.

Q2: How does Jevtana compare to emerging therapies for prostate cancer?
A2: Jevtana remains a key chemotherapeutic option with proven survival benefits, but competition from targeted therapies like PSMA radioligands and immunotherapies necessitates strategic positioning and combination approaches.

Q3: What are the main market challenges for Jevtana?
A3: High costs, reimbursement hurdles, and increasing competition from novel agents challenge its market share, particularly outside North America and Europe.

Q4: What is the outlook for Jevtana’s sales through 2028?
A4: Sales are projected to grow modestly to approximately USD 900 million–USD 1.2 billion, supported by rising prostate cancer prevalence and expanding clinical use.

Q5: Which regions offer the most growth potential for Jevtana?
A5: Asia-Pacific, Latin America, and the Middle East show significant opportunities due to increasing incidence rates and improving healthcare access.

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References

[1] Grand View Research. Prostate Cancer Therapeutics Market Size & Trends. 2022.
[2] FDA. Jevtana (cabazitaxel) prescribing information. 2010.
[3] NCCN Guidelines for Prostate Cancer. 2023.
[4] globocan. International Agency for Research on Cancer. 2021.