Eisai has launched its thyroid cancer therapy Lenvima in the UK, its first European market, and says it will roll the drug out across the EU in the coming months.
The launch of Lenvima (lenvatinib mesylate) in the UK comes just days after it was approved by the European Medicines Agency (EMA) for the treatment of adults with advanced thyroid cancer refractor to treatment with radioactive iodine.
The EMA gave a green light to the product late last month for use progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) after an accelerated, nine-month review.
UK pricing could not be confirmed as this article went to press, but in the US Lenvima is has a list price of $75,000-$83,700 for a 30-day supply.
DTC accounts for 95% of the 52,000 cases of thyroid cancer that are diagnosed each year in Europe, according to Eisai, which is also testing the drug in other cancers, including hepatocellular carcinoma (phase III) as well as renal cell carcinoma and non-small cell lung cancer (phase II).
The Japanese company also recently signed an agreement with Merck & Co to test the combination of Lenvima and PD-1 inhibitor Keytruda (pembrolizumab) in thyroid cancer and other solid tumours.
Lenvima was first approved and introduced in the US in February and is also available in Japan, with a launch in 20 more countries due by the end of fiscal 2015. Analysts have predicted that it could become a $1bn-a-year product by 2020, which would be a major boost to Eisai given lacklustre sales for its new weight-loss drug Belviq (lorcaserin).
In trials, radioactive iodine-refractory DTC patients treated with Lenvima lived a median of around 18 months without their disease progressing, compared to just over three months for those taking a placebo.
The drug is an oral kinase inhibitor that targets a number of cellular factors that can encourage tumour growth, including vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) and platelet-derived growth factor receptors (PDGF), as well as RET and KIT.
It will compete in Europe with Bayer’s kinase inhibitor Nexavar (sorafenib), which was approved for radioactive-iodine refractory DTC by the EMA last year and by the US FDA in 2013. At the time Nexavar was reported to be the first targeted therapy to become available for refractory DTC in four decades.
Lenvima is also under regulatory review in Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil.