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Eisai’s thyroid cancer drug Lenvima nears EU approval

Positive recommendation by the CHMP could see the orphan drug used in Europe within three months

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The European Medicines has fast-tracked its review of Eisai's new oncology drug for people with a rare type of thyroid cancer. 

The CHMP, the drug safety and efficacy arm of the EU regulator, has recommended Lenvima (lenvatinib) for the treatment of adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma (DTC), whose disease has progressed despite receiving radioactive iodine.

Lenvima was reviewed under the EMA's accelerated assessment programme, as it provides a new treatment option for these patients, and speeds up the overall time it takes to assess a new medicine.

This comes just one after the FDA approved the orphan drug for the same licence - the US regulated also allowed the drug to be reviewed under its accelerated approval system.

Martin Schlumberger, primary investigator and Professor of Oncology at the Institut Gustave Roussy, University Paris Sud, said: “Lenvatinib represents a paradigm shift in the treatment of advanced thyroid cancer, and will bring new options to patients and clinicians. Clinicians will be excited to prescribe a treatment with significant benefits in progression-free survival.

The drug is an oral kinase inhibitor that targets a number of mutations, including: vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), RET, KIT and platelet-derived growth factor receptors (PDGFR).

To date only one tyrosine kinase inhibitor, Bayer's Nexavar (sorafenib), has been approved in the EU for the treatment of DTC in patients who no longer respond to treatment with radioactive iodine.

The firm hopes it will gain significant market share from its rival, and said last year that it believes Lenvima can bring in $1bn a its peak. 

Thyroid cancer 

Thyroid cancer is a rare disease that affects the thyroid, a small gland at the base of the neck that produces thyroid hormones. DTC is the most common type of thyroid cancer. It is generally treated with surgery, radioactive iodine and thyroxine therapy to suppress thyroid-stimulating hormone (TSH). 

Most people have a good prognosis following standard treatments. However, in a small group of patients, the cancer progresses despite treatment with radioactive iodine.

Thyroid cancer affects more than 52,000 people in Europe each year and around 10% of patients with differentiated thyroid cancer do not respond to radioiodine treatment.

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

Lenvima has already been approved for the treatment of refractory thyroid cancer in the US and Japan.

AstraZeneca also has a thyroid cancer drug in the form of Caprelsa (vandetanib), although this has a different licence, namely for the treatment of aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Article by
Ben Adams

27th March 2015

From: Sales

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