A new drug being developed by Sanofi-Aventis extended the lives of men with advanced prostate cancer in a clinical trial and could become a new last-ditch treatment, researchers reported Wednesday.
Men whose cancer has spread beyond the prostate gland are usually treated with drugs that reduce the body’s production of testosterone, a hormone that can feed cancer growth. When such therapy fails, the only approved option now is the chemotherapy drug Taxotere, sold by Sanofi-Aventis, but that often fails as well.
The new chemotherapy drug, cabazitaxel, would step in when Taxotere stops working. It was tested in 755 men from 26 countries whose cancer continued to progress despite use of Taxotere.
In the clinical trial, men who received cabazitaxel lived a median of 15.1 months, compared with 12.7 months for those who received another cancer drug, mitoxantrone, a difference that was statistically significant.
Although mitoxantrone is not approved as a treatment for advanced prostate cancer, researchers said they believed it would be more ethical to compare the new drug to an active cancer medicine rather than to a placebo. The trial, in which all patients also received the steroid prednisone, was sponsored by Sanofi-Aventis.
The drug represents “a new therapeutic option for these patients who are very difficult to treat,” Dr. Oliver Sartor, a professor at Tulane Cancer Center and lead investigator of the trial in North America, said Wednesday in a telephone news conference.
He said that about 15,000 to 20,000 American men with advanced prostate cancer were now treated with Taxotere each year, but that 27,000 Americans died each year of the disease.
The trial results will be presented Friday at the Genitourinary Cancers Symposium in San Francisco, a conference sponsored by three medical groups.
Sanofi-Aventis said it hoped to complete its application to the Food and Drug Administration for approval of the drug in the first half of this year. Presuming it won approval, that would allow the drug to reach the market by late this year or early next.
Cabazitaxel did have a serious side effect. It depleted infection-fighting white blood cells and led to fever in 7.5 percent of patients, compared with 1.3 percent in those who got mitoxantrone.
Cabazitaxel is a taxane, a class of drug that also includes Taxol, sold as a generic as paclitaxel, and Taxotere, also known as docetaxel.
Cabazitaxel was developed to work in cancer cells that had become resistant to other taxanes. (NYT)