The mission of the American Association for Cancer Research
is to prevent and cure cancer. Founded in 1907, AACR is the world's
oldest and largest professional organization dedicated to advancing
cancer research. The membership includes more than 24,000 basic,
translational, and clinical researchers; health care professionals;
and cancer survivors and advocates in the United States and more
than 70 other countries. AACR marshals the full spectrum of expertise
from the cancer community to accelerate progress in the prevention,
diagnosis and treatment of cancer through high-quality scientific
and educational programs. It funds innovative, meritorious research
grants. The AACR Annual Meeting attracts over 17,000 participants
who share the latest discoveries and developments in the field.
Special Conferences throughout the year present novel data across
a wide variety of topics in cancer research, diagnosis and treatment.
AACR publishes five major peer-reviewed journals: Cancer Research;
Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular
Cancer Research; and Cancer Epidemiology, Biomarkers &
Prevention. Its most recent publication, CR, is a magazine
for cancer survivors, patient advocates, their families, physicians,
and scientists. It provides a forum for sharing essential, evidence-based
information and perspectives on progress in cancer research, survivorship
and advocacy.
Contact: Warren Froelich
American Association for Cancer Research
FDA Expands Use Of Herceptin For Early Stage Breast Cancer After
Primary Therapy
Main Category: Breast Cancer News
Article Date: 20 Nov 2006 - 0:00 PST
The U. S. Food and Drug Administration (FDA) today expanded the
approved use of Herceptin, a biological cancer drug. The new indication
is for Herceptin, in combination with other cancer drugs, for the
treatment of HER2 positive breast cancer after surgery (lumpectomy
or mastectomy). FDA granted priority review to the supplemental
application for Herceptin.
Herceptin is a targeted therapy against the HER2 protein on cancer
cells. When an excessive amount of HER2 protein is present, it causes
cancer cells to grow more rapidly and standard chemotherapy may
be less effective. In 1998, FDA approved Herceptin for the treatment
of metastatic breast cancer (cancer that has spread to other sites
in the body). Today's approval expands its use to women with cancer
only in the breast or lymph nodes which has been removed with surgery.
Herceptin should only be prescribed for women diagnosed with HER2
positive breast cancer.
"This is especially good news for women who have breast cancer
caused by excessive amounts of the HER-2 protein because this cancer
typically has a poor prognosis," said Dr. Steven Galson, Director
for FDA's Center for Drug Evaluation and Research.
The two studies leading to this new approved indication were conducted
by the National Cancer Institute-sponsored Cooperative Groups, a
multicenter clinical trials group. Patients in both trials received
standard chemotherapy after surgery for breast cancer; approximately
half the patients were also given Herceptin. The results from both
trials, which included information on nearly 4,000 women, were combined
and analyzed in 2005.
Due to positive results, the National Cancer Institute, a part
of the National Institutes of Health, ended the studies early. The
results showed that women who received Herceptin combined with chemotherapy
had fewer relapses (return of breast cancer) for up to three years
after surgery. The estimated three-year disease-free rates were
87 percent in women receiving Herceptin and chemotherapy and 75
percent in those receiving chemotherapy alone. It is too soon to
know whether Herceptin combined with chemotherapy will increase
the cure rate or lower the risk of death from breast cancer. In
the United States there are an estimated 212, 920 new cases of breast
cancer and about 40,970 related deaths each year. Approximately
25 percent of women with breast cancer will have tumors that produce
excessive amounts of HER2 protein.
The most serious side effect of Herceptin is heart failure (weakening
of the heart muscle) that requires medical treatment. Due to the
risk of heart disease, only certain patients should receive the
drug, including:
-- Only patients whose tumors are HER2 Positive
-- Patients who do not have heart failure or weak heart muscle (cardiomyopathy).
Patients must be screened for heart function before beginning and
during Herceptin treatment.
Less common but serious side effects include infusion reactions
(chills, fever, shortness of breath) that rarely are accompanied
by lung problems, low white blood counts, and low red blood cell
counts.
Herceptin (trastuzumab) is manufactured by Genentech, Inc, San
Francisco, CA.
http://www.fda.gov
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