Monday, June 21, 2010

Jevtana Approved for Prostate Cancer Three Months Ahead of Expectations

The Food and Drug Administration on today approved the first prostate cancer chemotherapy drug found to extend the survival of men who are no longer being helped by other treatments.
The drug is called Jevtana and it is made by Sanofi-Aventis of France. The FDA approved Jevtana to treat prostate cancer that does not respond to hormone-deprivation treatments or to docetaxel, the cancer drug most commonly used to fight prostate tumors. Earlier this year, a study showed Jevtana prolonged survival for those patients by 10 weeks.
Jevtana was approved for use in combination with the steroid prednisone, which is often used in cancer treatment.
In that study, patients who received a treatment regimen including Jevtana lived for about a year and three months after starting treatment. Those who received standard treatment lived for about a year and three weeks. There is hope the drug will have a stronger effect on patients who are not as sick.
Jevtana is given by injection. In the study, patients on Jevtana were more likely to have their tumors shrink than those who were on standard chemotherapy. However no patients in the study experienced a complete remission, or disappearance of all signs of the disease.
This is the second prostate cancer drug that was approved this year, giving prostate cancer patients new options. Prostate cancer, which usually occurs in older men, is the second-most common cause of cancer death among men in the U.S., behind lung cancer, according to Sanofi.

Sources: Associated Press OnLine, Sanofi-Aventis and Federal Drug Adminsistration