J&J breast cancer test should be approved: US panel
Last Updated: 2006-11-17 11:00:22 -0400 (Reuters Health)
By Susan Heavey
GAITHERSBURG, Md. (Reuters) - Veridex LLC's lab test to detect breast cancer that has spread to lymph nodes should be approved with certain conditions, a U.S. Food and Drug Administration advisory panel recommended on Thursday.
The company, which is part of Johnson & Johnson, is seeking U.S. approval for its GeneSearch Breast Lymph Node Assay to find cancerous growths in lymph node tissue removed from breast cancer patients.
The aim is to help surgeons quickly decide whether to remove more nodes during a surgery, or risk having the patient undergo a second operation.
In a 9-1 vote, the panel of outside experts said the test could give doctors more information to treat patients. The agency usually follows recommendations from advisory panels.
Still, the panelists questioned how well the test would help determine the best care for patients. The test does not show the size of the growths or how many a patient may have -- two things that can help decide further treatment, they said.
"I think what you're hearing from the panel is 'Yes, let's proceed forward but cautiously,'" said panelist Marc Ernstoff, a cancer immunologist at Dartmouth-Hitchcock Medical Center in New Hampshire.
Panelist Susanne Gollin, a professor of human genetics at the University of Pittsburgh, echoed others on the panel who expressed concern over the rate of invalid results.
"I'm really concerned about this 8.1 percent... I believe that this compromises patient care," she said.
Janet Vargo, director of clinical affairs for Veridex, told the panel the test, even with its limitations, was better than current methods, which rely on lab technicians to look at tissue with a microscope.
"The assay (test) can sample much more of the node and get a much better idea of what is going on," she said. "We are testing fresh tissue to give an immediate result to the surgeon."
Vargo said the test can deliver results in about 30 minutes compared to one current method that can take up to two days. Another method currently used can give results in up to 40 minutes but is not as accurate, she said.
But James Reeves, the FDA staffer who led the agency review, said there was no data to show it would take 30 minutes under real-world conditions. He also questioned the lack of long-term survival data, which would help determine whether knowing the test results actually helped patients live longer.
Breast cancer is the second most common form of cancer and the sixth-leading cause of death in U.S. women, according to the Centers for Disease Control and Prevention.
While it can be treated with surgery and certain drugs, like all cancers it can also spread to other parts of the body such as lymph nodes.
According to the American Cancer Society, it affects more than 200,000 American women each year and causes more than 40,000 deaths.
Shares of Johnson & Johnson closed 1 cent lower at $66.53 on the New York Stock Exchange before the news.
