Avastin OK’d for breast cancer
In a surprise decision that could portend significant changes in how federal regulators approve cancer drugs, the Food and Drug Administration Friday approved the use of a $100,000-a-year drug for use by women with breast cancer although there is little evidence it helps breast cancer patients live longer.
Avastin, manufactured by South San Francisco-based biotech giant Genentech Inc., is already a blockbuster cancer drug used to treat advanced colon and lung cancer. Research shows the drug slows the progress of breast cancer tumors by more than five months but does not extend patients’ lives.
Genentech submitted an application to the FDA two years ago to expand the drugs’ use to treat the 180,000 women in the U.S. with breast cancer. The drug works by cutting off blood and nutrients to tumor cells and is one of the highest-profile treatments of a new generation of so-called targeted cancer therapies.
Some doctors and patient advocates resisted expanding the drug’s use because the chief study of Avastin on breast cancer did not show that patients on the drug lived longer than those who didn’t take it, and it caused significant side effects including some deaths.
In December, an FDA advisory panel recommended 5 to 4 against approving the medicine for breast cancer.
The committee said Avastin’s benefit of slowing the spread of tumors wasn’t worth the risk of serious side effects. Although the FDA typically follows advisory panel recommendations, it occasionally does not.
Edward Lang, a spokesman for Genentech, called the decision an important advance for breast cancer patients. Although Avastin is “no cure for metastatic breast cancer, it doubled the time that women lived without their cancer worsening. That is an important benefit.”
Overall survival is considered the best measure of a drug. But it can be years before cancer patients die and decisive research about a drug’s gains can be done. So-called progression-free survival is a less meaningful research outcome, although some say it might be an important early indication of a drug’s benefit.
Friday’s surprise decision is an indication that the FDA appears willing to take that leap. Critics immediately attacked the approval.
“The bar has been lowered for the approval of cancer drugs and that is a loss for patients, period,” said Barbara Brenner, executive director of the advocacy group Breast Cancer Action and a breast cancer survivor. “We all want good drugs as long as they provide a real benefit. This drug does not.”
Others are just as concerned about how expensive Avastin and the rest of a new generation of cancer drugs are for patients, considering the small upside.
Although some of the drugs have produced spectacular results, most bring only marginal benefits. Beyond adding to overall healthcare costs, some patients are spending tens of thousands of dollars a year out of pocket for the medications.
Genentech said those who spend more than $55,000 a year (including insurance) on Avastin will be eligible for free medication.
Many doctors already have been using Avastin to treat breast cancer by prescribing it off-label. Federal approval means more are likely to prescribe it and more insurers are likely to cover it.
Dr. Dennis J. Slamon, a breast cancer oncologist at UCLA’s Jonsson Comprehensive Cancer Center, said he believed that the drug was an important breast cancer treatment and that it would show a survival effect in future research.
“As a physician treating patients I want to have this drug available to me so I can consider all possible therapeutic approaches for my patients,” he said.
Avastin was Genentech’s bestselling drug last year, bringing in $2.3 billion. But its sales have slowed of late. Sales of the drug in breast cancer patients could be worth as much as $1 billion a year or more, analysts estimate.
Technically, Genentech was given an “accelerated approval” for the drug by the FDA, meaning the company will have to provide additional supporting data. It’s highly likely the approval will stay in place as long as upcoming trials don’t include any surprises.
Last week Genentech said early results of a separate study, dubbed Avado, also showed the drug slowed cancer progression, helping allay fears that the first trial could have been a fluke. Another large study is also ongoing.
Genentech’s shares rose $5.80, or 8%, to $77.40 in after-hours trading Friday.
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