Sanofi-aventis announced that Jevtana (cabazitaxel) injection is now available in the United States for patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-based treatment regimen. The availability of Jevtana comes just one month following a priority review and approval by the US Food and Drug Administration (FDA).

“The prostate cancer community is thrilled to now have a new treatment option available for these patients whose disease is very difficult to treat,” said 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. “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.”

Jevtana, a microtubule inhibitor, is approved in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-based treatment regimen. Jevtana is to be administered intravenously. Jevtana was granted fast track designation by the FDA in November 2009. The rolling new drug application (NDA) submission was completed in March 2010 and was granted priority review in April 2010; Jevtana was approved by the FDA less than three months later. A registration dossier of Jevtana is also under regulatory review by other regulatory authorities, including the European Medicines Agency.

Jevtana in combination with prednisone was approved based on results from the phase 3 TROPIC clinical study involving 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 patients 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 patients receiving Jevtana plus prednisone was 15.1 (14.1–16.3) months compared to 12.7 (11.6–13.7) months for patients receiving mitoxantrone plus prednisone.

“For many years, treatment of advanced hormone refractory prostate cancer after docetaxel-containing therapy has remained an unmet medical need. The ability to introduce Jevtana for this patient population is an important achievement for sanofi-aventis Oncology that exemplifies our deep commitment to bringing innovative new therapies to the cancer community,” said Debasish Roychowdhury, M.D., senior vice president, global oncology, sanofi-aventis.

For patients with metastatic prostate cancer, hormone therapy is frequently the first treatment offered. Patients who no longer respond to hormone therapy often receive chemotherapy. However, some patients develop chemotherapy resistance, and their disease continues to progress. Before Jevtana, no available second-line treatment options were proven to provide a survival benefit in mHRPC patients. The combination of Jevtana and prednisone is the first and only therapy to have shown a significant survival benefit for patients with mHRPC previously treated with a docetaxel-containing regimen in this setting.

In the TROPIC Study, the most common (= 10%) grade 1-4 adverse reactions were anaemia, leukopenia, neutropenia, thrombocytopenia, diarrhoea, 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 patients who received Jevtana were neutropenia, leukopenia, anaemia, febrile neutropenia, diarrhoea, fatigue, and asthenia. Treatment discontinuations due to adverse drug reactions occurred in 18% of patients 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 diarrhoea-induced dehydration and electrolyte imbalance.