CAMBRIDGE, Mass., Dec. 17 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that the U.S. Food and Drug Administration
(FDA) has approved a supplemental indication for Thyrogen(R) (thyrotropin
alfa for injection) to be used in combination with radioiodine to ablate,
or destroy, the remaining thyroid tissue in patients who have had their
cancerous thyroids removed. Remnant ablation is a procedure that patients
commonly undergo when being treated for thyroid cancer.
"This new indication extends the significant benefits of Thyrogen to
patients during their initial treatment for thyroid cancer, in addition to
its current use in follow-up diagnostic procedures to detect recurrence,"
said Mike Heslop, senior vice president and general manager of Genzyme's
endocrine business. "This is an important milestone in our ongoing effort
to expand the clinical applications of Thyrogen to improve patient care."
The American Cancer Society estimates that in 2007, about 33,550 new
cases of thyroid cancer will be diagnosed in the United States.
Approximately 90 percent of all thyroid cancers are well-differentiated,
making those patients candidates for the remnant ablation procedure.
"The development of new treatment options for thyroid cancer patients
is critical, as this disease has the fastest rising incidence of all
cancers among women in the U.S.," said clinical investigator Paul Ladenson,
M.D., professor and director of endocrinology at The Johns Hopkins
University School of Medicine. "The availability of Thyrogen for use in
remnant ablation is a notable advance, as it permits patients to maintain a
good quality of life during the course of their thyroid cancer treatment
and follow-up testing."
Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001
for use as a diagnostic tool in the management of patients being tested for
the recurrence of well-differentiated thyroid cancer. The product helps
increase the sensitivity of testing while allowing patients to avoid the
potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme
received additional European approval for Thyrogen's use during remnant
ablation procedures in 2005.
Thyrogen Use in Ablation
The new indication allows Thyrogen to be used in conjunction with
radioiodine for the most common approach to treating thyroid cancer. This
includes surgical removal of the cancerous thyroid followed by remnant
ablation, which destroys any remaining thyroid tissue. This can help reduce
the risk of disease recurrence and facilitate follow-up monitoring.
In remnant ablation, patients take a drink or a capsule that contains
radioactive iodine, which is taken up by any remaining thyroid cells. To
enhance the uptake of radioiodine, the level of thyroid stimulating hormone
(TSH) in a patient's bloodstream must be enhanced. Patients currently stop
taking thyroid hormone supplements to elevate TSH levels. Doing so,
however, often causes side effects associated with hypothyroidism, which
may include fatigue, difficulty concentrating, short-term memory impairment
and depression. Thyrogen is a recombinant form of TSH that is administered
by injection, allowing patients to continue taking hormone supplements and
avoid the symptoms associated with hormone withdrawal.
The FDA approved Thyrogen for remnant ablation based on results from a
pivotal clinical study which suggest that treatment with Thyrogen is
similar to withdrawal from thyroid hormone in achieving ablation, and that
it could significantly reduce the side effects of thyroid hormone
withdrawal by allowing patients to remain on hormone replacement therapy.
Most cases of thyroid cancer are discovered during a routine physical
examination when a painless lump is found in the thyroid. It is three times
more common in women than in men. Although well-differentiated thyroid
cancer is very treatable, ongoing monitoring is important as the disease
can recur in up to 30 percent of patients.
About Thyrogen
Thyrogen is currently available in more than 45 countries. It was first
approved in the United States in 1998 for use in patients with well-
differentiated thyroid cancer who have had their thyroid removed as an
adjunctive diagnostic tool for serum thyroglobulin testing with or without
radioiodine imaging. These patients must take thyroid hormone supplements
and undergo periodic testing for recurrent or metastatic cancer. Thyrogen
allows patients to remain on their hormone supplements during this testing
and avoid the debilitating symptoms of clinical hypothyroidism.
With the new approval, Thyrogen may also be used as an adjunctive
treatment for radioiodine ablation of thyroid tissue remnants in patients
with well-differentiated thyroid cancer who have recently had their thyroid
removed and who do not have evidence of metastatic thyroid cancer.
Thyrogen is injected in a muscle, and is available only by
prescription. The most common side effects reported in clinical studies
were nausea, headache, fatigue, vomiting and dizziness. When using Thyrogen
as a diagnostic tool, there is a risk that thyroid cancer cells may not be
detected and diagnosis of recurring cancer may be missed. Please see full
prescribing information at http://www.thyrogen.com
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,500 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was selected by FORTUNE as one of the "100 Best
Companies to Work for" in the United States.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
Genzyme(R) and Thyrogen(R) are registered trademarks of Genzyme
Corporation. All rights reserved.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line at
1-800-905-4369 within the United States or 1-678-999-4572 outside the
United States.
Media Contact: Investor Contact:
Erin Emlock Leah Rosenberger
(617) 768-6923 (617) 768-6602
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
http://www.thyrogen.com
http://www.prnewswire.com/comp/113803.html/
CONTACT:
Media: Erin Emlock, +1-617-768-6923, or
Investors: Leah Rosenberger, +1-617-768-6602, both of Genzyme
Corp.
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