About FDA


On June 17, 2010, the U.S. Food and Drug Administration (FDA) approved cabazitaxel (Jevtana Injection, sanofi-aventis) for use in combination with prednisone for treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. 

The approval is based primarily on the results of a randomized, open-label, international trial of 755 patients with mHRPC previously treated with docetaxel-containing regimens.  Patients were randomized to receive either cabazitaxel 25 mg/m2 intravenously every three weeks in combination with prednisone 10 mg/day or mitoxantrone 12 mg/m2 intravenously every three weeks in combination with prednisone 10 mg/day.   Patients were treated until disease progression, death, unacceptable toxicity, or completion of 10 cycles of therapy. 

Median survivals were 15.1 and 12.7 months for cabazitaxel-treated and mitoxantrone-treated patients, respectively [HR 0.70 (95% CI 0.59-0.83), p<0.0001.]  Investigator-assessed response rates using RECIST criteria was 14.4 and 4.4% for cabazitaxel-treated and mitoxantrone-treated patients, respectively, p=0.0005.  No complete responses were observed on either arm.

The most common (≥10%) grade 1-4 adverse reactions included neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia and alopecia.  The most common (≥5%) grade 3-4 adverse reactions were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue and asthenia.

Deaths due to causes other than disease progression within 30 days of the last dose were reported in 18 (5%) cabazitaxel-treated patients and 3 (<1%) mitoxantrone-treated patients.  The most common fatal adverse reactions in cabazitaxel-treated patients were infections (n=5), and renal failure (n=4).  One death was due to diarrhea-induced dehydration and electrolyte imbalance.

G-CSF may be administered to reduce the risks of neutropenic complications associated with cabazitaxel use.  Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features including age > 65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities.  Therapeutic use of G-CSF and secondary prophylaxis should be considered in patients at an increased risk for neutropenia complications.

Because of the risk of severe hypersensitivity, patients should be premedicated with an antihistamine, a corticosteroid and an H2 antagonist.  In addition, antiemetic prophylaxis is recommended.


Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf


Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).



Page Last Updated: 11/27/2015
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