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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.


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NEWS HIGHLIGHTS

Media Articles Related to Jevtana (Cabazitaxel)

Arno Therapeutics enrolls first patient in a Phase I/II trial evaluating onapristone in men with advanced castration-resistant prostate cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.04.09]
Arno Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, has announced that it has enrolled the first patient in a Phase I/II trial...

Radiotherapy plus six months of hormone therapy improves prostate cancer survival
Source: Endocrinology News From Medical News Today [2014.04.09]
The findings, which were presented at the 33rd conference of the European Society for Radiotherapy and Oncology (ESTRO33) in Vienna, are expected to change clinical practice.

For active monitoring of prostate cancer, non-invasive imaging can be used instead of repeated biopsy
Source: MRI / PET / Ultrasound News From Medical News Today [2014.04.09]
Your body's cells have two major interconnected energy sources: the lipid metabolism and the glucose metabolism.

Research suggests prostate cancer may be prevented by circumcision
Source: Prostate / Prostate Cancer News From Medical News Today [2014.04.09]
Men circumcised after the age of 35 were 45% less at risk of later developing prostate cancer than uncircumcised men, as shown by researchers at the University of Montreal and the...

Prostate cancer patients given brachytherapy more likely to maintain erectile function
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.04.08]
In approximately 50% of patients with prostate cancer, the use of permanent brachytherapy, a procedure where radioactive sources are placed inside the prostate, into or near to the tumour, preserves...

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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.

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.

A multicentre dose-escalating study of cabazitaxel (XRP6258) in combination with capecitabine in patients with metastatic breast cancer progressing after anthracycline and taxane treatment: a phase I/II study. [2011.05]
BACKGROUND: Most patients with metastatic breast cancer (MBC) progress after chemotherapy. Cabazitaxel (XRP6258) is a new taxoid that is active in chemotherapy-resistant tumour cell lines. The objectives of this phase I/II study were to assess the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and activity of cabazitaxel plus capecitabine in patients with MBC who had been previously treated with taxanes and anthracyclines... CONCLUSIONS: Cabazitaxel combined with capecitabine is active, has a safety profile consistent with a taxane plus capecitabine combination and warrants further investigation in patients with MBC. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

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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 - PF Induction Chemotherapy [Recruiting]
The primary objective of this study is to determine the first-cycle maximum tolerated dose (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck for three cycles.

Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer [Recruiting]
Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at < 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.

Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer [Recruiting]
This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles.) and androgen deprivation therapy (Treatment to suppress or block the production or action of male hormones) in patients with locally advanced prostate cancer.

It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control can be achieved and eventually the cure rate can be increased. After this study, the maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can be found.

Men with locally advanced high risk prostate cancer represent a group of patients for whom cure is potentially achievable utilizing a multimodality approach. More aggressive treatment upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel approach will improve disease control and eventually improve survival for locally advanced prostate cancer patients.

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.

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Page last updated: 2014-04-09

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