Hey interesting facts here pizza..."The FDA granted an...

Hey interesting facts here pizza...


"The FDA granted an accelerated conditional approval for Avastin in February 2008 to treat late-stage breast cancer patients."

The accelerated approval process has been in place in 1992. Since 1995, a total of 49 new indications for 37 cancer drugs have been approved under the FDA?s accelerated approval program, and clinical benefit has been confirmed for most of these indications, according to Erica Jefferson, a spokeswoman for the Center for Drug Evaluation and Research.

The accelerated approval process has been an invaluable tool that allows the agency to ?speed up? a patient?s ability to get access to new drugs that show promise. This happened first with HIV drugs and in the past decade with cancer therapies.

and here abit about being unsafe (cvac IS safe)

?But the premise of the program is that if confirmatory studies don?t confirm that promise or show meaningful results for patients, or the drug is found to be unsafe, CDER has to withdraw the product or indication in the interest of public health,? Jefferson said.

and ref to competition here...

Avastin is the only anti-angiogenic medicine approved for the treatment of metastatic breast cancer, which cuts off the flow of blood to tumors to starve the tumor, said Terry Kalley, whose wife is benefiting from the drug. ?There is no other one like it.?

According to Roche, there are no cures for breast cancer that has metastasized.

and data on numbers affected.here..

According to the National Cancer Institute, a component of the National Institutes of Health, 207,090 women in the U.S. were diagnosed with breast cancer in 2010, and almost 40,000 died of the disease. Based on current rates, NCI estimates that one in every eight women born today will be diagnosed with breast cancer at some time in their lives.


Great info for future of new technolgies such as cvac (if it passes FDA and EMA approval that is)