Breast cancer drug receives FDA approval
LEXINGTON, Ky. (Nov. 17, 2006) − A new use for the breast cancer drug Herceptin was approved by the FDA yesterday, a move that means more treatment options for the 25 percent of breast cancer patients with early-stage HER-2 positive breast cancer.
Dr. Edward Romond, a cancer specialist and researcher at UK HealthCare's Markey Cancer Center, was instrumental in researching and analyzing the results of two massive clinical trials of early-stage breast cancer patients who received Herceptin in combination with chemotherapy. The results indicated a 52 percent decrease in the risk for breast cancer recurrence compared with patients who received the same chemotherapy without Herceptin. "In terms of a single leap forward, this is probably the most dramatic we've had in a long time," Romond said.
The study revealed the use of Herceptin in early-stage HER-2 positive breast cancer was effective. Herceptin was previously only used in late-stage breast cancer or cancer that had spread to other sites. The effectiveness of this new treatment therapy offers hope to the 25 percent of breast cancer patients who have HER-2 positive breast cancer, which is an extremely aggressive and fast-spreading cancer. This study has changed the outcome from one of the most worrisome kinds of cancer to one that has a much better prognosis, Romond said.
The NCI-sponsored national clinical trial featured more than 500 testing sites throughout the United States and Canada and included 3,351 women. Romond has since become the national spokesperson for this new use of Herceptin in treating early-stage HER-2 positive breast cancer.
Romond is a professor of medicine in the University of Kentucky College of Medicine, and is a cancer specialist at the UK HealthCare Markey Cancer Center. He was the principal investigator for the Herceptin study, and also chaired the same study for the National Surgical Adjuvant Breast and Bowel Project. He also recently was honored with the 2006 Celebration of Life Award from the Lexington affiliate of the Susan G. Komen Foundation for his breast cancer research efforts and excellent patient care.
More information on the Herceptin study, along with Romond's comments, can be read in an issue of Advances & Insights from UK HealthCare.
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