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Jevtana (Cabazitaxel) - Summary



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 (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 >>


Media Articles Related to Jevtana (Cabazitaxel)

Little Evidence That Vasectomy Raises Prostate Cancer Risk
Source: MedicineNet Mens Health Specialty [2017.07.19]
Title: Little Evidence That Vasectomy Raises Prostate Cancer Risk
Category: Health News
Created: 7/18/2017 12:00:00 AM
Last Editorial Review: 7/19/2017 12:00:00 AM

Vasectomy Does Not Raise Prostate Cancer Risk: Study
Source: Medscape Pathology & Lab Medicine Headlines [2017.07.18]
Men considering a vasectomy shouldn't worry that the procedure will increase their risk of prostate cancer, researchers say.
Reuters Health Information

Surgery No Better Than Observation for Early Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2017.07.17]
Long-term follow-up of men in the PIVOT study shows that observation, not surgical intervention, may be a better option. But not for all men, says an expert.
Medscape Medical News

Surgery for early prostate cancer may not save lives
Source: Prostate / Prostate Cancer News From Medical News Today [2017.07.17]
Most men just as likely to survive with limited or no treatment.A major 20-year study provides further evidence that prostate cancer surgery offers negligible benefits to many men with...

Higher risk of aggressive prostate cancer in taller and heavier men
Source: Cancer / Oncology News From Medical News Today [2017.07.13]
The risk of aggressive prostate cancer is increased in taller men and those with a higher BMI and waist circumference, according to a new study.

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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.

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.

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Clinical Trials Related to Jevtana (Cabazitaxel)

Cabazitaxel - PF Induction Chemotherapy [Completed]
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.

Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU) [Recruiting]
Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.

Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer [Withdrawn]
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.

Study of Weekly Cabazitaxel for Advanced Prostate Cancer [Active, not 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.

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.

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Page last updated: 2017-07-19

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