- Text
Avastin's breast cancer approval revoked by FDA
(Credit:
CBS)
(CBS/AP) Avastin for breast cancer is out. The FDA says the drug should no longer be used for breast cancer because there's no proof it extends patients' lives - and it causes dangerous side effects.
PICTURES: 25 breast cancer myths busted
Friday's ruling was long expected. An FDA advisory panel in June unanimously voted to revoke Avastin's approval for treating breast cancer over those concerns, CBS News reported.
"I think we all wanted Avastin to succeed but the reality is that these studies did not bear out that hope," Natalie Compagni-Portis, a patient representative on the FDA's panel, said at the time.
But the ruling is sure to disappoint women who say they've run out of other options.
FDA Commissioner Dr. Margaret Hamburg called the decision difficult but said patients must have confidence that drugs sold for their condition are effective.
The FDA granted Avastin accelerated approval in 2008 based on one study in which it slowed breast cancer tumor growth for more than five months when combined with chemotherapy. But in follow-up studies the delay shrunk to less than three months. Across all studies, patients taking Avastin did not live any longer and suffered side effects like infection, high blood pressure, and blood clots.
Avastin won't stop selling, as it's also used to treat colon cancer and certain other tumors. But the FDA ruling is expected to influence insurance coverage. Medicare says it will continue to cover Avastin while it evaluates whether a change is needed.
Back in June when the FDA's panel first made its recommendation, doctors' opinion was split.
"I think the FDA is doing the right thing since the drug has some serious complications," said Dr. Stephanie Bernik of Lenox Hill Hospital in New York. "However, there are definitely patients who are benefiting from the drug and if the FDA completely withdraws approval those patients may find it hard to get access."
- Marvel creates "Blue Ear" superhero for deaf boy
- Skin cancer self-exam: What to look for (PHOTOS)
- Christina Hendricks: Too Big for Hollywood?
- Sperm gene discovery may lead to male birth control
- Pool access for the disabled causes controversy
- Pizza Hut adds hot dog stuffed crust pizza in U.K.
- Salmonella dog food scare causes recall
- Study links calcium pills to heart attacks
- Time breastfeeding cover sparks debate
- Poisoning risk from mini laundry detergent packs
- PICTURES: 15 Shocking Sexual Fetishes
- Scientists uncover how epilepsy diet works
- Listeria found in lettuce spurs nationwide recall
- Did Reality Shows Drive Contestants to Suicide?
- Anti-Rape Condoms Fight World Cup Sex Assault
- Life-size Barbie's shocking dimensions
