Genzyme Receives European Label Expansion for Thyrogen
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced it has
received European Commission approval of a product label expansion for
the use of Thyrogen (thyrotropin alfa) with a wider
irradiation dose range for postoperative thyroid remnant ablation.
Thyrogen is used before radioiodine treatment to avoid temporarily
discontinuing thyroid replacement therapy for postoperative thyroid
remnant ablation. The revised indication in remnant ablation provides
physicians with the option to administer a reduced dose of radioiodine
(131-I). Previously the amount of radioiodine was specified at 100 mCi,
whereas physicians may now select a dose from the range of 30 to 100 mCi.
It has long been debated whether smaller amounts of radioiodine for
patients with low-risk thyroid cancer would improve care, said
Professor Martin Schlumberger, M.D., Institut Gustave Roussy, University
Paris Sud, Paris, France. The expanded Thyrogen indication provides a
new option for many physicians who may be reducing radioiodine use due
to uncertainty about impact on recurrences and mortality in low-risk
patients as well as short- and long-term safety concerns.
The decision to approve the expanded indication for use of Thyrogen in
Europe is based on the results of the two largest studies (HiLo and
ESTIMABL) ever conducted in thyroid remnant ablation. The studies,
published in the in May 2012,
evaluated whether rates of successful ablation would be similar among
patients receiving recombinant human thyrotropin (rhTSH), patients
undergoing thyroid hormone withdrawal (THW), and among patients
receiving low or high amount of radioiodine.
In the two studies, 30 mCi of radioiodine were well tolerated and showed
similar success rates for low-dose radioiodine plus rhTSH vs. high-dose
plus THW or rhTSH. In both studies, patients receiving Thyrogen rather
than THW had fewer hypothyroid symptoms and better preserved quality of
"The best path to achieve thyroid remnant ablation must be one that
involves the least whole body radiation dose, the least early and late
side-effects, the best quality of life, and the least healthcare and
societal costs, as demonstrated in the HiLo and ESTIMABL trials, said
Ujjal Mallick, M.D., Northern Centre for Cancer Care, Freeman Hospital,
These findings have been reflected in the updated Summary of Product
Characteristics (SmPC) and apply to all 27 EU member states, plus
Iceland and Norway.
Thyrogen (thyrotropin alfa for injection) is for patients with
well-differentiated thyroid cancer. Thyrogen is approved as an
adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or
without radioiodine imaging. Thyrogen is also approved in the U.S. and
Europe as an adjunctive treatment for radioiodine ablation of thyroid
tissue remnants in patients who have undergone a near total or total
thyroidectomy for well-differentiated thyroid cancer and who do not have
evidence of metastatic thyroid cancer.
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzymes portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the worlds largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme and Thyrogen are registered trademarks
of Genzyme Corporation. All rights reserved.