Dendreon Corp fka DNDNQ

[steveporsche]

Pazdur Comment on Avastin BC Approval:

We felt this is an effective drug for breast cancer,'' said Richard Pazdur, director of the agency's Office of Oncology Drugs, in a telephone interview. It was important to know that a second study [post marketing approval study], which the FDA requested, confirmed the benefit, Pazdur said.

The drug didn't show it could help people live longer in the E2100 study, although that could have been skewed by unknown circumstances, Pazdur said. The FDA still believes survival is the ``gold standard'' for cancer drugs, and if further Avastin studies don't demonstrate a benefit, the agency may require another advisory panel, he said.

http://www.bloomberg.com/apps/news?pid=20601103&sid=arfpSr.Bqdqc&refer=us

[but Breast Cancer Action were against approval]:

Breast Cancer Action, a patient advocacy group in San Francisco, said in a statement the decision is ``a victory for drug companies, but not for patients.'' The group argued that the FDA lowered its standards by approving the medicine without showing it improved survival time.

Patients on the drug had a 20 percent increase in serious side effects, including high blood pressure, blood clots and heart attack, the FDA said.