The Food and Drug Administration Thursday started the process of removing approval for the use of a common cancer drug to treat breast cancer.
The FDA said the drug, Avastin, isn’t effective enough, and its dangerous side effects outweigh any possible benefits.
Avastin was given accelerated approval in 2008 after a study showed it prevented cancerous tumors from growing for five and a half months. But subsequent studies showed a much smaller benefit – as little as less than a month of so-called “progression free survival.”
But all drugs affect different people in different ways, and there are women who swear by Avastin.
A patient disagrees
Priscilla Howard is one of those women. Sitting in her office on the campus of Muhlenberg College in Allentown, she's proud to say that since she was diagnosed with cancer more than four years ago, she's only missed 10 or 15 days of work. Even when her drugs gave her bad blisters on her feet, she would still show up.
"I would manage to get up the stairs and then announce to everyone 'the princess is in the tower, she is not coming down,' ” Howard said.
Howard, 71, was diagnosed with cancer in her right breast and lymph nodes four years ago. She had surgery, chemo and radiation, but she has "triple negative" cancer. Because that type of cancer is not fed by hormones, drugs commonly used to prevent cancer from coming back wouldn’t work on her.
“It was kind of like waiting for the shoe to drop, and it dropped,” Howard said. “I found a lump under my arm within a year, and yep, it was cancerous. The cancer had moved to my right lung.”
Howard started on Avastin and a chemotherapy drug shortly after she discovered that her cancer had spread. And the combination worked for her. Within a three or four months, her oncologist, Dr. Gregory Harper, said her scans were clean.
"It worked wonderfully for her,” Harper said. “We've had no evidence of recurrence and there's been no new disease.”
Harper said there's no way to know which of the drugs Howard takes is keeping the tumor from coming back. He has seen other patients react well to the combination, but Howard has been able to remain on the drug longer than any of his other patients – more than two years.
The problem is, the drug hasn't worked as well for everyone. In July, an independent advisory panel to the FDA voted 12 to 1 to remove approval for the drug for the treatment of metastatic breast cancer.
Missing the gold standard
Dr. Joanne Mortimer, an oncologist at City of Hope, a cancer center in California, was on the advisory board. She said making decisions about cancer treatments can get emotional, and there are often people who swear a certain treatment is working for them.
But this drug just doesn't have the numbers to back its use for breast cancer. Overall, it wasn't shown to prolong life, the gold standard for first-line cancer treatments.
"If you're a patient, you want to know that you're not just chipping away at the edges of the cancer,” Mortimer said. “You want to know that you'll live longer because of that."
The FDA also cited concerns about the drug's serious side effects, including hypertension, kidney problems and increased risk of death. Mortimer said it seemsthat for a minority of women, such as Priscilla Howard, Avastin does help prevent the growth of tumors.
And the FDA said it supports further studies that might allow it to be approved only for patients it would be most likely to help. But until a method is developed to determine who will be helped before treatment is given, Mortimer said the risks of widely prescribing the drug outweigh any possible benefits.
"Before we expose all these patients to an increased risk of side effects and the cumbersome thing of coming to get chemotherapy, and the cost, you really want to know who are the women who are going to benefit,” Mortimer said. “To give a toxic drug without knowing for certain that a patient is going to benefit from it is possibly producing harm."
Taking side effects in stride
Howard has experienced side effects. She's now on medication for hypertension, and she's had to skip her treatment a few times because she showed evidence of kidney distress. But she said managing those risks is part of any cancer treatment, and, like any other treatment, a good partnership with her oncologist is key.
“When my body rejects [the drug] then my body rejects it, and I can accept that,” Howard said. “But I can't accept a group of individuals saying your life isn't worth it."
Genentech, the company that makes the drug, said it will request a hearing to appeal the FDA's decision. The ruling likely won't be finalized for months; until then, the medication can continue to be prescribed for breast cancer. After that, the drug will remain on the market for lung, colon and brain cancer.
But if the FDA's removal goes through, insurance companies likely wouldn't cover the drug for the treatment of breast cancer. And at an estimated wholesale cost of $88,000 a year, the drug will be out of reach for many women.
Howard said she'll take Avastin for as long as she can, and then hope that her current chemotherapy drug is enough to keep her tumors at bay.