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Jevtana (Cabazitaxel) - Summary

 
 



WARNING

Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving JEVTANA. JEVTANA should not be given to patients with neutrophil counts of ≤1,500 cells/mm3.

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 [see Warnings and Precautions]. Patients should receive premedication [see Dosage and Administrations]. JEVTANA must not be given to patients who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80 [see Contraindications (4) ].

 

JEVTANA SUMMARY

JEVTANA (cabazitaxel) is an antineoplastic agent belonging to the taxane class. It is prepared by semi-synthesis with a precursor extracted from yew needles.

JEVTANA® is a microtubule inhibitor indicated in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.


See all Jevtana indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Jevtana (Cabazitaxel)

Screening Men With a Family History of Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.12.18]
Men with a family history of prostate cancer may be more likely to have prostate cancer themselves, but do they benefit from the screening process? Dr Gerald Chodak discusses the latest research.
Medscape Urology

A yardstick to measure the malignancy of prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2014.12.10]
A protein that influences the epigenetic characteristics of tumor cells is directly linked to the grade of malignancy of prostate cancer.

Prevention of prostate cancer growth and spread achieved in animal studies
Source: Lung Cancer News From Medical News Today [2014.12.09]
Researchers at Georgetown Lombardi Comprehensive Cancer Center have completed a critical step in the journey from a basic science discovery in the lab to a potential clinical application, showing...

Xtandi™ (enzalutamide) now licensed for use in the UK to treat men with advanced prostate cancer, following initial hormone treatment failure
Source: Prostate / Prostate Cancer News From Medical News Today [2014.12.08]
XTANDI TM(enzalutamide) is now licensed in Europe and is already funded in England on the Cancer Drugs Fund,2 for the treatment of adult men with metastatic castration-resistant prostate cancer...

Association between common prostate cancer treatment and decreased survival in older men
Source: Prostate / Prostate Cancer News From Medical News Today [2014.12.08]
A common prostate cancer therapy should not be used in men whose cancer has not spread beyond the prostate, according to a new study led by researchers at Henry Ford Hospital.

more news >>

Published Studies Related to Jevtana (Cabazitaxel)

TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. [2011.04]
For patients with metastatic castration-resistant prostate cancer (mCRPC), the current standard of care is chemotherapy involving the tubulin-binding taxane docetaxel. However, as the tumor cells become resistant to docetaxel-based therapy, disease progression is inevitable, and until recently there was no further available treatment beyond palliative care.

Cabazitaxel for the second-line treatment of metastatic hormone-refractory prostate cancer: a NICE single technology appraisal. [2013]
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cabazitaxel (Jevtana®, sanofi-aventis, UK) to submit evidence of its clinical and cost effectiveness for the second-line treatment of metastatic hormone-refractory prostate cancer (mHRPC)... They concluded that whilst the clinical effectiveness of cabazitaxel had been proven, it was not likely to represent a cost-effective use of NHS resources and so its use could not be recommended.

Managing side effects of the novel taxane cabazitaxel in castrate-resistant prostate cancer. [2012]
Cabazitaxel, a novel taxane, was approved in June 2010 by the U.S. Food and Drug Administration for treatment of metastatic castrate-resistant prostate cancer (mCRPC) in men previously treated with docetaxel... This article reviews the vital role of nurses in identifying patients at high risk for AEs associated with cabazitaxel therapy and reviews strategies for prevention and management of symptoms.

The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use. [2012]
On March 17, 2011 the European Commission issued a marketing authorization valid throughout the European Union for Jevtana® (Sanofi-Aventis, Paris, France) for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen... The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency Web site (http://www.ema.europa.eu).

Cabazitaxel: a novel microtubule inhibitor. [2011.07.09]
The development of drug resistance is a major obstacle to effective cancer therapy. Several agents are in clinical development with the goal of overcoming resistance... This article presents the preliminary antitumour activity, safety, tolerability and pharmacokinetic data of cabazitaxel, and an overview of the current status of clinical development.

more studies >>

Clinical Trials Related to Jevtana (Cabazitaxel)

Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor [Recruiting]
Primary Objectives:

- 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.

- 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,

and 2,2 difluoridine 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.

- To assess the potential inhibitory effect of cabazitaxel on CYP3A4 using midazolam, a

CYP3A4 probe since cabazitaxel inhibits CYP3A4 in vitro.

Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer [Not yet recruiting]
Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and older) with advanced prostate cancer who have progressed during or after treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help the body produce more white blood cells, which should help decrease the risk of getting an infection while being treated with cabazitaxel.

Phase I/II Cabazitaxel for Recurrent Malignant Glioma [Not yet recruiting]
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be studied in both parts.

Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell division.

Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer [Recruiting]
This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research.

This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy.

Patients must meet the study eligibility criteria and must be competent to give informed consent.

Study of Weekly Cabazitaxel for Advanced Prostate Cancer [Not yet recruiting]
This is a multicenter open label non randomized phase II clinical trial of Weekly Cabazitaxel for Advanced Prostate Cancer in Hormone-Refractory Patients Previously Treated with Docetaxel.

The purpose of this study is to evaluate the activity of the weekly administration of cabazitaxel as time to progression by PSA at week 12.

more trials >>


Page last updated: 2014-12-18

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