Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health) | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Rhone Poulenc Rorer
Approval Status: Approved May 1996
Treatment Area: breast cancer
Taxotere has been approved as a treatment for subjects who have
locally advanced or metastatic (spreading) breast cancer, which has
progressed during anthracycline-based therapy or has relapsed
during anthracycline-based adjuvant therapy. Approximately two out
of three breast cancer subjects treated with chemotherapy in the
United States receive anthracyclines at some point in the treatment
of their disease.
Anthracycline-based chemotherapy is commonly used by oncologists
as initial therapy for metastatic disease and as adjuvant
chemotherapy administered in conjunction with surgery to prevent
disease recurrence. In subjects with advanced disease, their cancer
will eventually become resistant and stop responding to the
Unlike other chemotherapeutic agents, Taxotere can be
administered outside the hospital.
The approved outpatient regimen for Taxotere is 60 to 100 mg/m2
administered intravenously for one hour every three weeks. Other
currently used chemotherapy agents may require hospitalization due
to much longer infusion times.
As of June 1998, Taxotere is approved for first-line treatment
of metastatic breast cancer in subjects whose disease has recurred
despite adjuvant therapy.
In worldwide phase II clinical trials, Taxotere demonstrated the
highest tumor response rates ever reported for a single agent in
this subject population.
Taxotere has been studied extensively in clinical trials
involving thousands of subjects worldwide, including the United
States, Canada, Japan, and Europe. Additional clinical trials are
ongoing to investigate the potential use of Taxotere to treat other
Side effects have been shown to be predictable and manageable.
They include hair loss, reduced white blood cell count, skin rash,
fluid retention, hypersensitivity, nausea, and diarrhea.
Mechanism of Action
Taxotere is a new chemical entity that inhibits cancer cell
growth, which depends on the formation of an internal cellular
skeleton made up of elements called microtubules. During the cell
development cycle, microtubules first assemble and then
disassemble, permitting cancer cells to divide and thus allow tumor
growth. Taxotere essentially freezes the cancer cell's internal
skeleton by promoting the assembly and blocking the disassembly of
microtubules. This action prohibits cancer cell division, which
causes cell death.
In the United States, breast cancer is the most common form of
cancer in women. Each year 183,000 new cases are diagnosed and
nearly 45,000 subjects die. Although many women are treated
successfully initially, about 50% of breast cancer subjects will
eventually relapse or recur. When this happens, the cancer often
metastasizes or spreads beyond the breast to other parts of the
body, such as the liver or bone. For women between the ages of 40
and 55, metastatic breast cancer is the leading cause of death.