DALLAS—It's been a roller coaster ride for the breast cancer drug Avastin--the FDA gave accelerated approval just three years ago but now an advisory panel had ruled that it's not safe or effective in treating breast cancer.
Dr. Hania Alaidroos of Arbor Green Family Medical Clinic in Dallas, TX said the ruling is heartbreaking news for patients.
"From the patient's point of view this was one of the few drugs uses for metastatic breast cancer," Dr. Alaidroos said. "However you have to follow evidence based medicine and it's just not showing the kind of response that we were hoping it would."
The FDA originally granted approval for the late stage breast cancer drug after an early study indicated it slowed tumor growth.
Later studies found the drug didn't work as previously thought and may cause side effects including an increased the risk of dying.
The FDA says that no trial has shown that patients who used Avastin lived longer than those who did not.
Some breast cancer patients consider it an outrage to revoke approval of a drug that they believe works.
"It is morally and ethically wrong to stop treatment for those who are benefitting," One woman told the panel.
Dr. Alaidroos said that rational is called 'incidental findings' and they generally don't add up.
"Someone comes in and says thing helped me, it's on an individual basis," Dr. Alaidroos said. "When we are looking at number, we are looking at large number you have to go by statistics and statistically it's not showing benefit."
Avastin is still approved for brain, colon, kidney and lung cancer and doctors can still prescribe the drug for breast cancer but because approval will likely be revoked insurers may not pay for it.
Dr. Alaidroos said new information doesn't support recommending such an expensive drug with what appears to have limited benefits.
"Yes, we want insurance to cover things but at the same time do we really want them to cover very, very expensive medications, close to $100,000 a year in a medication that may not work or may be actually be doing more harm than good."
The recommendation is not a done deal; FDA commissioner will likely make a final decision by the end of July.