General Information

Jevtana (cabazitaxel) is an orally bioavailable taxane anti-neoplastic agent. It works by disrupting the microtubular network that is essential for mitotic and interphase cellular functions and causes inhibition of cell division and cell death. Cabazitaxel has been shown to inhibit cell division and tumor cell proliferation by binding to and stabilizing tubulin, a protein in the microtubules of cells which provides a skeleton for maintaining cell shape.

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

Jevtana is supplied as a solution for intravenous administration. Patients should be premedicated at least 30 minutes prior to each dose of Jevtana with the following intravenous medications to reduce the risk and/or severity of hypersensitivity: antihistamine, corticosteroid or H2 antagonist. The individual dosage of Jevatana is based on calculation of the Body Surface Area and is 25 mg/m2 administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout Jevtana treatment. The Jevtana dose should be reduced to 20 mg/m2 if one of the following adverse reactions occurs: prolonged grade >3 neutropenia for more than one week despite medication; febrile neutropenia or Grade >3 diarrhea or persisting diarrhea despite appropriate medication. Jevtana should be discontinued if a patient continues to experience any of these reactions at 20 mg/m2.

Clinical Results

FDA Approval
The FDA approval of Jevtana was based on a randomized, open-label, international, multi-center study. The trial enrolled a total of 755 patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. The subjects received either Jevtana 25 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone 10 mg orally daily or mitoxantrone 12 mg/m2 intravenously every 3 weeks for 10 cycles with prednisone 10 mg orally daily for a maximum of 10 cycles. In the Jevtana + prednisone arm there were 61.9 % deaths while there were 74% deaths in the mitoxantrone + prednisone arm. The median survival was 15.1 months in the Jevtana + prenisone arm and 12.7 months in the mitoxantrone + prednisone arm. Investigator-assessed tumor response of 14.4% was higher for patients in the Jevtana arm compared to 4.4% for patients in the mitoxantrone arm (p=0.0005).

Side Effects

Adverse events associated with the use of Jevtana may include, but are not limited to, the following:

• Anemia
• Leukopenia
• Neutropenia
• Thrombocytopenia
• Diarrhea
• Fatigue
• Nausea
• Vomiting
• Constipation
• Asthenia
• Abdominal pain
• Hematuria
• Back pain
• Anorexia
• Peripheral neuropathy
• Pyrexia
• Dyspnea
• Dysguesia
• Cough
• Arthralgia
• Alopecia

Mechanism of Action

Cabazitaxel is an orally bioavailable taxane anti-neoplastic agent. It works by disrupting the microtubular network that is essential for mitotic and interphase cellular functions and causes inhibition of cell division and cell death. Cabazitaxel has been shown to inhibit cell division and tumor cell proliferation by binding to and stabilizing tubulin, a protein in the microtubules of cells which provides a skeleton for maintaining cell shape.

Additional Information

For additional information regarding Jevtana or prostate cancer, please visit the sanofi aventis web page.