Sanofi-aventis announced it has received marketing authorization from the European Commission for Jevtana (cabazitaxel) in combination with prednisone/prednisolone for the treatment of patients with metastatic Hormone-Refractory Prostate Cancer (mHRPC) previously treated with a docetaxel-containing regimen. Jevtana is the first approved agent to significantly extend overall survival in mHRPC patients whose disease has progressed during or after treatment containing docetaxel (15.1 months median overall survival vs 12.7 months in the mitoxantrone arm; HR=0.70 (95% CI: 0.59-0.83); P<0.0001).

The approval from the European Commission followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The decision is based on the results from the phase III TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. The European Commission decision is applicable to the 27 Member States of the European Union (EU) as well as Iceland, Lichtenstein and Norway. Jevtana was previously approved in the US, Israel, Curaçao and Brazil.

“Jevtana in combination with prednisone/prednisolone reduced the risk of death by nearly one third and extended progression-free survival compared to mitoxantrone, an active comparator,” said Debasish Roychowdhury, MD, senior vice president and Head, Global Oncology Division, sanofi-aventis. “The European approval of Jevtana offers new hope for patients across Europe with limited treatment options should their disease progress following first-line therapy.”

Worldwide, prostate cancer ranks third in cancer incidence and sixth in cancer mortality in men. In the US, prostate cancer remains the second most common cause of cancer death among men after lung cancer. For many patients with prostate cancer, their disease continues to progress despite prior treatment – including surgical and/or hormonal castration followed by chemotherapy. Metastatic prostate cancer indicates that the cancer has spread to the lymph nodes or other parts of the body, particularly the bones. Castration resistant/hormone-refractory prostate cancer means that the cancer has continued to grow despite the suppression of male hormones that fuel the growth of prostate cancer cells. An estimated 10-20 percent of patients with prostate cancer are diagnosed when the cancer has already metastasized.

Results from the TROPIC trial demonstrated a 30 percent [HR=0.70 (95% CI: 0.59-0.83); P<0.0001] reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone or prednisolone, compared with a chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone or prednisolone. In addition, the median survival of patients receiving Jevtana was 15.1 months, 2.4 months higher than patients receiving mitoxantrone.

In the TROPIC Study, the most common (= 10%) adverse events grade >3 were anaemia, leukopenia, neutropenia, thrombocytopenia and diarrhoea. The most common (= 5%) grade 3-4 adverse reactions in patients who received Jevtana were neutropenia, leukopenia, anaemia, febrile neutropenia and diarrhoea.

Jevtana is a semi-synthetic taxane and works differently than docetaxel and paclitaxel. An antineoplastic agent, it acts by disrupting the microtubular network in cells. It binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly. This leads to the stabilization of microtubules. Jevtana demonstrated a broad spectrum of anti-tumour activity against advanced solid tumours xenografted in mice. Jevtana is active in docetaxel sensitive tumours. In addition, Jevtana demonstrated activity in tumour models insensitive to chemotherapy, including docetaxel.

Sanofi-aventis Oncology, a division of sanofi-aventis, is translating science into effective cancer therapeutics to address unmet medical needs for patients with cancer. It is committed to the pursuit of science and innovative cancer therapies. We believe in partnership with leading experts, and combining that expertise with our own internal scientific strength and heritage. There are currently more than 10 compounds in clinical development including small molecules and biological agents.

Sanofi-aventis, discovers, develops and distributes therapeutic solutions to improve the lives of everyone.