Sanofi-aventis, the pharmaceutical company that makes taxotere and the newly approved drug, Jevtana (cabazitaxel) yesterday announced that their newly approved treatment for men with metastatic hormone-refractory prostate cancer (mHRPC) who have been previously treated with a docetaxel-based treatment regimen and failed is finally available for distribution in the United States. Around one month ago, Jevtana was approved by the U.S. Food and Drug Administration (FDA), but it has not been available.

Jevtana which is used in combination with prednisone was approved by the FDA based on results from the Phase 3 TROPIC clinical study which involved 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. Results from this trial demonstrated:

* a statistically significant 30%

[HR=0.70 (95% CI: 0.59-0.83); P<0.0001] relative reduction in the risk of death in mHRPC among men taking Jevtana in combination with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone.* Median overall survival in the men receiving Jevtana plus prednisone was 15.1 (14.1–16.3) months compared to 12.7 (11.6–13.7) months for men receiving mitoxantrone plus prednisone.Jevtana is not an easy drug to take. Participants in the he TROPIC Study experienced significant negative side effects:*The most common adverse side effect (? 10%) were grade 1-4 adverse reactions consisting of anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.*The most common (? 5%) grade 3-4 adverse reactions in men who received Jevtana were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia.*Treatment discontinuations due to adverse drug reactions occurred in 18% of the men who received Jevtana and 8% of patients who received mitoxantrone.*The most common adverse reactions leading to treatment discontinuation in the Jevtana group were neutropenia and renal failure.*Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) Jevtana patients and three (less than 1%) mitoxantrone-treated patients.* The most common fatal adverse reactions in Jevtana patients were infections (n=5) and renal failure (n=4).*One death was due to diarrhea-induced dehydration and electrolyte imbalance.Oliver Sartor, M.D., Piltz Professor for Cancer Research at Tulane Medical School, New Orleans, and North American principal investigator for the pivotal TROPIC trial, said “Jevtana will help fill a critical treatment gap, since it is the first treatment approved for patients with this stage of metastatic hormone-refractory prostate cancer.”Sanofi-aventis hasalso announced they will offer education and information programs to healthcare providers, advocacy organizations and patients. The company has included Jevtana in its PACT+ program, which offers reimbursement-support services, patient-assistance programs and alternative services to help provide eligible patients in financial need with access to the company’s medicines. Patients and healthcare professionals can get more information on the PACT+ program by calling 1-800-996-6626. In addition, the company provides direct financial support to foundations supporting the needs of patients, with the collective goal of helping patients access sanofi-aventis medicines.Important Safety Information for Jevtana – 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. Patients should receive premedication.

• 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.

The information in this post was supplied directly from Sanofi-aventis.

Joel T Nowak, MA, MSW