Avastin: FDA Snub of Breast Cancer Drug Stirs Debate

SOUTH SAN FRANCISCO, CA - JULY 14: A sign is displayed in front of the Genentech headquarters July 14, 2008 in South San Francisco, California. Biotech firm Genentech will release its second quarter earnings today and will be relying on the popularity of its cancer drug Avastin to boost profits. (Photo by Justin Sullivan/Getty Images)
(Photo by Justin Sullivan/Getty Images)
Genentech/Roche is the maker of the controversial cancer drug Avastin (Justin Sullivan/Getty Images)


(CBS/AP) Breast cancer patients are up in arms over the FDA's recent recommendation that the drug Avastin no longer be used to treat breast cancer.

Recent studies indicate that Avastin does not affect overall survival of metastatic breast cancer patients - and causes significant side effects - but some patients credit their survival to the drug and say the FDA's action could amount to a death sentence.

Christi Turnage of Madison, Miss., said her cancer has been undetectable for more than two years since starting therapy with Avastin. She was diagnosed with breast cancer in June 2006 and began taking the drug in 2008 after the tumors spread, or metastasized, to her lungs. Breast cancer that spreads to other parts of the body is generally considered incurable.

"It's a miracle drug for me and for several of my friends, and to deny it to women being diagnosed with metastatic disease is wrong," Turnage said.

Patients like Turnage have support from Susan G. Komen for the Cure, a leading advocacy group.

"We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it," the group's president, Elizabeth Thompson, said in a statement. The organization also wants to make sure insurers will continue to pay for the expensive drug, she added.

The FDA's recommendation will not have an immediate impact on breast cancer patients. Avastin's manufacturer has 15 days to file an appeal for a public hearing and a process of review that could take months.

The recommendation will not affect patients taking the drug for various types of colon, lung, kidney, and brain cancer, for which Avastin is also approved.

The FDA approved Avastin for breast cancer in 2008 based on one study suggesting it halted the spread of breast cancer for more than five months when combined with chemotherapy. But follow-up studies showed that the delay lasted no more than three months, and patients suffered dangerous side effects.

"Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio," said Dr. Richard Pazdur, FDA's chief of cancer drug review.

It seems the debate will not be resolved anytime soon.