Genzyme Receives European Label Expansion for Thyrogen
Label will Enable Additional Usage in Patients for Postoperative Thyroid Remnant Ablation
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, 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 New England Journal of Medicine 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 life.
"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, Newcastle UK.
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.
About Genzyme, a Sanofi Company
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. Genzyme's 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 world's 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.
Ingrid Mitchell, 617-768-6699
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