New Drug for Advanced Prostate Cancer

Article date: September 16, 2010

The Food and Drug Administration (FDA) recently approved a new drug called cabazitaxel (Jevtana) for men with advanced prostate cancer that is resistant to hormone therapy and not responding to treatment with the chemotherapy drug docetaxel (Taxotere). Before the approval of cabazitaxel, docetaxel was the only FDA-approved option for men with advanced, hormone-refractory disease.

Because of its potential to help men with late-stage prostate cancer, the drug, made by Sanofi-Aventis, was fast-tracked for FDA approval.

“Patients have few therapeutic options in this disease setting,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products, part of the FDA’s Center for Drug Evaluation and Research, at the time of the approval. “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.”

Improved survival

The FDA based its approval on results from the TROPIC study, which compared the overall survival of 378 men who got cabazitaxel with 377 who got mitoxantrone (another chemotherapy drug sometimes used to treat prostate cancer). Both groups of men also received prednisone. All of the men had previously been treated with docetaxel. Researchers found men who got cabazitaxel lived about 10 weeks longer on average than men who received mitoxantrone.

Side effects of cabazitaxel can include a decrease in infection-fighting white blood cells, anemia, a decrease in blood platelets, diarrhea, fatigue, nausea, vomiting, constipation, weakness, allergic reactions, peripheral nerve damage, and kidney failure.

While cabazitaxel is promising for men with advanced disease, some health professionals have expressed some concerns about the toxicity of the drug. Further research should help better define the drug's safety profile.

About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. While more than 2 million men in the US who have been diagnosed with prostate cancer are still alive today, about 32,050 men are expected to die of prostate cancer in 2010.