FDA approves Jevtana, which extended survival of men not helped by other prostate cancer drugs

FDA approves Sanofi-Aventis prostate cancer drug

NEW YORK — The Food and Drug Administration 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 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.

“Patients have few therapeutic options in this disease setting,” said Richard Pazdur, director of the FDA’s Office of Oncology Drug Products. Sanofi-Aventis said it expects the drug to be available this summer.

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.

The FDA said Jevtana’s side effects including 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 FDA has approved two potentially groundbreaking prostate cancer treatments this year. It cleared Dendreon Corp.’s immune-based therapy Provenge in April. The agency said prostate cancer is the second most common cancer among men in the U.S. The disease usually occurs in older men.

The ruling on Jevtana came more than three months early, as the FDA was scheduled to make a decision on the drug by Sept. 30. The drug was developed under the name cabazitaxel. Jevtana is also being reviewed by regulators in other markets, including the European Union.

Sanofi-Aventis shares slid 12 cents to $31.72 on Thursday.