Sanofi and Genzyme granted EU approval for Thyrogen expansion

Sanofi and Genzyme's thyroid cancer therapy Thyrogen has received European regulatory approval for a new labelling update.

The new product label expansion will allow the drug to be used with a wider irradiation dose range for postoperative thyroid remnant ablation, allowing doctors to utilise a reduced dosage if needs be.

Data from clinical trials showing that low-dose versions of the treatment can offer similar efficacy and tolerability rates were used to support the latest regulatory filing.

Professor Martin Schlumberger at the University Paris Sud said: "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."

Thyrogen is also approved in the US and Europe as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging.

Last month, the company announced the appointment of Brendan Martin as new Genzyme general manager for the UK and Ireland, succeeding Paul Drohan.