LEVATINIB FOR THYROID CANCER

The European Medicines Agency (EMA) has recommended marketing authorization for lenvatinib (Lenvima, Eisai) for the treatment of progressive, locally advanced, or metastatic differentiated thyroid carcinoma in adults whose disease has progressed despite standard treatment with radioactive iodine.

Lenvatinib was approved by the US Food and Drug Administration for these same treatment-refractory patients last month. The agency granted the drug priority review, and approved it 2 months ahead of schedule.

The EMA also sped up its process; lenvatinib was reviewed under the accelerated assessment program and now moves on to the European Commission for a ruling on European-wide marketing authorization, which is usually granted within 67 days.

Progressive or advanced thyroid cancer is a rare disease with few treatment options and a poor prognosis.

Lenvatinib, a tyrosine kinase inhibitor, has an orphan drug designation. Currently, one other tyrosine kinase inhibitor, sorafenib (Nexavar, Bayer), is approved in the European Union for the treatment of differentiated thyroid carcinoma in patients who progress on standard treatment.

The provisional EMA approval was given on the basis of results from the pivotal phase 3 SELECT trial, which demonstrated an improvement in progression-free survival (N Engl J Med. 2015;372:621-630).

Specifically, median progression-free survival was better in patients treated with lenvatinib than with placebo (18.3 vs 3.6 months; hazard ratio for progression or death, 0.21; 99% confidence interval, 0.14 - 0.31; P < .001).

The response rate was also dramatically better with lenvatinib (64.8% vs 1.5%; P < .001).

"Based on these results, lenvatinib will probably become the standard of care in this population," said SELECT investigator Martin Schlumberger, MD, from the Institut Gustave Roussy and University Paris-Sud in Villejuif, France. He spoke with Medscape Medical News when the trial data were published last month.

The most common adverse effects of lenvatinib were hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.

If European marketing authorization is granted, a decision about price and reimbursement will take place at the level of each country and their national health system.