Sanofi-aventis announced that the US Food and Drug Administration (FDA) has granted marketing authorization for Jevtana (cabazitaxel) injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

Jevtana, a microtubule inhibitor, 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 per cent [HR=0.70 (95 per cent CI: 0.59-0.83); P<0.0001] reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone. Investigator-assessed tumour response rates using Response Evaluation Criteria in Solid Tumours (RECIST) were 14.4 per cent and 4.4 per cent for cabazitaxel-treated and mitoxantrone-treated patients respectively, p=0.0005. No complete responses were observed on either arm.

"This is truly a significant announcement for the prostate cancer community, addressing an unmet medical need. With the approval of Jevtana, health care professionals now have a new treatment option for patients with the most advanced stage of prostate cancer and for whom there have been few options," said Oliver Sartor, MD, TROPIC North American principal investigator, Piltz Professor for Cancer Research at Tulane Medical School, New Orleans. "Jevtana in combination with prednisone is the only FDA approved regimen to significantly improve overall survival in patients previously treated with docetaxel-based chemotherapy."

"This is a proud time for sanofi-aventis Oncology. Phase III study results with Jevtana were significant for a prostate cancer compound since it successfully demonstrated a survival benefit compared to active control in a second-line treatment setting," said Debasish Roychowdhury, MD, senior vice president, global oncology, sanofi-aventis. "Jevtana builds on sanofi-aventis Oncology's long legacy of providing innovative oncology medicines to patients around the world."

In the TROPIC Study, the most common (? 10%) adverse reactions (grade 1-4) were neutropenia, anaemia, leukopenia, 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. The most common adverse reactions leading to treatment discontinuation in the Jevtana group were neutropenia and renal failure. Treatment discontinuations due to adverse drug reactions occurred in 18% of patients who received Jevtana and 8% of patients who received mitoxantrone. 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.

Jevtana 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 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. Jevtana is expected to be available as a marketed product in the USthis summer. A registration dossier of Jevtana is also under regulatory review by other regulatory authorities, including the EMA.