Sanofi-aventis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Jevtana (Cabazitaxel – 60mg concentrate and solvent for solution for infusion) in combination with prednisone or prednisolone for the treatment of patients with metastatic Hormone-Refractory Prostate Cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

The positive opinion from the CHMP needs now to be ratified by the European Commission.

“Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Jevtana in the European Union,” said Debasish Roychowdhury, MD, senior vice president and Head of Global Oncology, sanofi-aventis. “The response to Jevtana in the US has exceeded our expectations. The positive opinion for Jevtana in the European Union now strengthens sanofi-aventis Oncology’s goal of providing substantially beneficial cancer medicines to patients around the world.”

The CHMP positive opinion is based on the submission of results from the phase III 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 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 an active 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, a statistically significant difference.

In the Tropic Study, the most common (= 10%) adverse events (grade 1-4) 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 currently approved in the United States and Brazil. Jevtana has also been submitted to regulatory agencies in 26 countries spanning four continents.

Jevtana is an antineoplastic agent that acts by disrupting the micro-tubular 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, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel.

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. In 2009, an estimated 192,000 new cases were anticipated in the US, while 27,000 men were expected to have died from the disease.

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.

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