The European Commission (EC) has issued marketing authorisation for 'Lenvima' (lenvatinib) in the treatment of people with radioactive iodine refractory differentiated thyroid cancer.

Differentiated thyroid cancer accounts for 90% of all thyroid cancers and 5-15% of people with differentiated thyroid cancer will develop advanced thyroid cancer that is refractory to radioactive iodine.

Lenvatinib is indicated for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).

“The decision by the European Commission will be welcomed by physicians and patients across Europe. I am proud to have led the SELECT study, and people living with advanced thyroid cancer will now have access to this significantly effective drug,” commented Martin Schlumberger, Professor of Oncology, Institut Gustave Roussy, University Paris Sud, Paris, France.

Lenvatinib demonstrates a clinically meaningful and significant median progression free survival of 18.3 months in the lenvatinib group and 3.6 months in the placebo group.

The response rate was 64.8% in the lenvatinib group (4 complete responses, 1.5%) and 1.5% in the placebo (p<0.001).

70.4% of patients had a complete or partial response to lenvatinib within 30 days on the 24mg dose.

Lenvatinib was associated with a median time to objective response of 2 months (95% CI, 1.9-3.5).

Median duration of treatment was 13.8 months with lenvatinib versus 3.9 months for placebo.

SELECT is a randomised, double-blind, multicentre trial for people with progressive radioactive iodine refractory differentiated thyroid cancer (n=392).

For lenvatinib, the most common treatment related adverse events were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.

Lenvatinib, discovered and developed by Eisai, is an oral molecular tri-specific targeted therapy that possesses a potent selectivity and a binding mode of action different to other tyrosine kinase inhibitors (TKI).

Lenvatinib simultaneously inhibits the activities of several different receptors including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), RET, KIT and platelet-derived growth factor receptors (PDGFR).

This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3.

In addition, lenvatinib was found to have a new Type V binding mode of kinase inhibition that is distinct from existing compounds.

Thyroid cancer affects more than 52,000 people in Europe each year.

Thyroid cancer is the most common endocrine malignancy.

Approximately 5-15% of people with differentiated thyroid cancer do not respond to radioactive iodine treatment and is known as radioactive iodine refractory differentiated thyroid cancer.

Approximately 2,000 people in Europe live with this difficult to treat and life threatening illness for which there are few treatment options.

Lenvatinib has been approved for the treatment of refractory thyroid cancer in the United States and Japan, and has been submitted for regulatory approval in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.

Lenvatinib was granted Orphan Drug Designation in Japan for thyroid cancer, in the United States for treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer and in Europe for follicular and papillary thyroid cancer.

Source: Eisai