Jevtana approved by regulators

Jevtana: Approved

Sanofi-Aventis' chemotherapy agent Jevtana has been approved by US regulators along with the steroid prednisone in order to treat men with prostate cancer. Combined, the two drugs are the first therapy to have shown a significant survival benefit for patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen.

Generally for mHRPC, hormone therapy is generally the treatment first offered and recommended, but for those who no longer respond to hormone therapy, chemotherapy is often the next step. However some patients are known to develop chemotherapy resistance, and their disease continues to progress.

According to InPharm, before Jevtana, no available second-line treatment options were proven to be any sort of benefit to mHRPC patients.

Speaking of the regulators' decision, Debasish Roychowdhury, senior VP of global oncology at Sanofi-Aventis, said: "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."

Clinical studies

The decision to approve Jevtana was based on results from a phase III TROPIC clinical study that involved 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen.

Median overall survival in the patients receiving Jevtana plus prednisone was just over 15 months compared to 12.7 months for patients receiving mitoxantrone plus prednisone.

It was then reviewed under the FDA's priority review programme, which offers an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists.

Jevtana received rapid approval and the treatment has now been approved.

"Patients have few therapeutic options in this disease setting," said Richard Pazdur, director of the Office of Oncology Drug Products, part of the FDA's Center for Drug Evaluation and Research. "FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer."

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