FDA Approves Prostate Cancer Drug Jevtana

The FDA on Thursday 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, Jevtana, was approved for the treatment of 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 (cabazitaxel) prolonged survival for those patients by 10 weeks.

In the study, patients who received a treatment regimen including Jevtana injections 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.

"Patients have few therapeutic options in this disease setting," said Richard Pazdur, director of the FDA's Office of Oncology Drug Products.

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.

The FDA said Jevtana's side effects included decreased levels of infection-fighting white blood cells and lower white blood cell count, anemia, lower levels of blood platelets, diarrhea, fatigue, nausea, vomiting, constipation, weakness and kidney failure.

The drug's maker, Sanofi-Aventis, said it expects the drug to be available this summer.

The agency said prostate cancer is the second most common cancer among men in the U.S. The disease usually occurs in older men.
CBS/AP