Sanofi-Aventis is celebrating the news that regulators in the USA have given the green light to Jevtana, its chemotherapy drug for advanced prostate cancer, more than three months earlier than expected.
The US Food and Drug Administration has granted marketing authorisation for Jevtana (cabazitaxel) in combination with prednisone for the treatment of patients with metastatic hormone-refractory
prostate cancer (mHRPC) previously on a docetaxel-containing treatment regimen. The approval is the result of the FDA’s priority review programme, which provides for an expedited six-month analysis for drugs that may offer major advances in treatment; Jevtana received approval well ahead of the product’s September 30 goal date.
Jevtana, a microtubule inhibitor, in combination with prednisone, was approved based on results from the Phase III TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing therapy. Data demonstrated a statistically significant 30% reduction in risk of death from mHRPC among patients taking the combo compared with chemotherapy consisting of mitoxantrone and prednisone.
The speed of the review is eye-catching and Richard Pazdur, director of the Office of Oncology Drug Products at the FDA, noted that the company was able to study and approve the application for Jevtana in just 11 weeks. Sanofi quoted Oliver Sartor at Tulane Medical School, New Orleans, as saying that “this is truly a significant announcement for the prostate cancer community, addressing an unmet medical need”. He noted that doctors now have a new treatment option for patients with the most advanced stage of prostate cancer “and for whom there have been few options”.
