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EC approves cabozantinib as second-line treatment for radioiodine-refractory differentiated thyroid cancer

DTMT Network

French pharmaceutical company Ipsen has said that the European Commission (EC) has approved its cabozantinib, marketed under the brand Cabometyx as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy.

The approval is based on data from the COSMIC-311 Phase III trial, in which cabozantinib demonstrated a 78% reduction in risk of disease progression or death versus placebo, Ipsen said in a media release.

“The nature of radioiodine-refractory differentiated thyroid cancer means that this condition does not respond to the most commonly used standard of care for differentiated thyroid cancer,” Dr Jaume Capdevila, Medical Oncologist at the Vall d´Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, and a trial investigator said.

“As a result, people living with this form of the disease have had limited treatment options should their disease progress,” he added.

Welcoming the approval, Ipsen’s Chief Medical Officer and Head of Global Medical Affairs and Global Patient Safety Dr Steven Hildemann said, “We are delighted that the European Commission has recognised the strength of the COSMIC-311 data and the possibilities that Cabometyx can deliver for people living with radioactive-iodine-refractory differentiated thyroid cancer.”

We are committed to researching areas of oncology with high unmet medical needs and this decision exemplifies our ambition to bring meaningful new treatments that have the potential to make tangible differences in people’s lives,” he added.

It may be noted that thyroid cancer is the ninth most prevalent cancer worldwide affects women more than men and differentiated thyroid cancer makes up to 95% of all thyroid cancers.


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