 WASHINGTON,
D.C. (FDA News) -- Taxotere
(docetaxel) was approved today by the U.S.
FDA for treatment---in combination with prednisone---of men with
advanced metastatic prostate cancer. The Taxotere approval thus marks
the first time in history that a treatment which prolongs life has gained
FDA sanction for hormone-refractory prostate cancer.
The approval was based largely on the results of a 1000-man
clinical trial showing that Taxotere + prednisone extended life an average
of 2.5 months longer than the control group treated with mitoxantrone
+ prednisone. Details of the pivotal prostate study, known as TAX 327,
will be presented at a plenary session of the American
Society for Clinical Oncology June 7, 2004 in New Orleans, LA.
Taxotere has been approved
in the U.S. since 1996, first to treat patients with locally advanced
or metastatic breast cancer after failure of prior chemotherapy and
later, for non-small-cell lung cancer.
 The
drug works by inhibiting
tubulin, which is a protein component of microtubules serving as
the cell skeleton. Normally, microtubules
are flexible constructions that play a crucial role in the dynamic process
of cell division. For example, microtubules are the major constituents
of the cellular apparatus known as the mitotic spindle, which helps
to separate the chromosomes during cell mitosis. When taxoids attach
to microtubules, they become extremely stable and static, making cell
division impossible, thus killing the cells just as they begin to divide.
The drug is typically given by intravenous infusion every
3 weeks.
Adverse effects include hematological
toxicity, particularly neutropenia, a maculopapular rash and other skin
changes, predisposition to infections, and gastrointestinal affections.
Adverse events may have increased frequency and severity in men with
abnormal liver function.
 Taxotere
is a member of the taxoid family and a semi-synthetic derivative
of the yew plant. Taxol (paclitaxel), the first commercial taxoid, was
discovered in the early 1970's as part of a National Cancer Institute
screening of many species of higher plants for anticancer activity.
Taxotere was brought to market by the French pharmaceutical firm Rhone-Poulenc,
which was later acquired by Aventis
Pharmaceuticals. Aventis will soon be acquired by Sanofi
Synthelabo.
LINKS:
Taxotere (docitaxel)
package insert
Scientific
American article explains how Taxotere came to be
Kimball’s Biology
describes “The Cytoskeleton”
Nature
Review on microtubules as anti-cancer drug targets
Review
Article on Taxotere for Hormone Refractory Prostate Cancer |
