FDA to Widen Use of Late-Stage Breast Cancer Drug
MADELEINE BRAND, host:
This is DAY TO DAY. I'm Madeleine Brand.
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I'm Alex Chadwick.
Today the Food and Drug Administration is expected to extend approval for a highly effective anti-cancer drug. It's been show to help women with an aggressive form of breast cancer. NPR's Patricia Neighmond reports.
PATRICIA NEIGHMOND: The drug called Herceptin is already approved for late stage breast cancer. It literally works its way into the cancer cell, binds to a protein that promotes cancer growth, and destroys that protein along with the cancer cell. Dr. Edith Perez headed research into the drugs effectiveness for early breast cancer. She works with the Mayo Clinic in Jacksonville Florida.
Dr. EDITH PEREZ (Researcher, Mayo Clinic, Jacksonville Florida): By giving this therapy, added to other standard therapies, such are surgery and chemotherapy, we can further decrease the risk of the cancer returning by 52 percent. We can improve the likelihood that people will be alive at three to four years, by a third.
NEIGHMOND: Which means after surgery, chemo, and Herceptin treatment, 87 percent of breast cancer patients were alive after three years. Patients are still being followed says Perez, and nearing the six year mark, the drug still looks effective. This is remarkable news, Perez says, especially since the type of cancer Herceptin works against is particularly aggressive. It's called Her2 Positive Breast Cancer.
Dr. PEREZ: They look more aggressive under the microscope and they tend to return quicker, and they tend to lead to increased death rate compared to Her2 Negative Breast Cancers.
NEIGHMOND: About a year and a half ago researchers, including Dr. Perez, made a dramatic decision. They called a halt to two studies examining the effectiveness of Herceptin in early cancer because the drug had been so successful. Over three thousand women were taking part in the study. After the studies were stopped, all of the women were offered the treatment. 36 year-old Christy Maines was lucky. She took part in the study and received Herceptin all along. She was only 32 when she was diagnosed with breast cancer. She had a 16- month-old baby.
Ms. CHRISTY MAINES (study participant): There was a 70 percent chance that because of the size of my tumors and the spread in the 18 months node size, there was a 70 percent chance that it would metastasize in other organs within five years and there was little hope of survival.
NEIGHMOND: Maines is convinced Herceptin saved her life. And today her life is healthy and whole.
Ms. MAINES: Oh I'm perfect. I'm running my third marathon next month. I'm in great health. Now my daughter is five. I didn't think I'd see her go to kindergarten, and you know, she's five - so it's a whole new life.
NEIGHMOND: There are side effects to Herceptin. Christy Maines says she had none. But in about three-and-a-half percent of women it causes congestive heart failure. But that can easily be treated, says Dr. Perez, with typical heart medications like ACE Inhibitors and BETA Blockers. Herceptin costs about $50 thousand a year. It's given by injection once a week for one year. Most insurers do cover the cost. Perez says that FDA approval would make treatment even more widely available to breast cancer patients by eliminating any doubt doctors might have about prescribing the treatment and by encouraging insurance companies to pay for it.
Patty Neighmond, NPR News.
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