First launch for Eisai's Lenvima, in the USA

The US subsidiary of Japanese pharma major Eisai (TYO: 4523) has now launched its in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) as a treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in the USA.

The US Food and Drug administration approved Lenvima last month, two months sooner than had been expected (The Pharma Letter February 14, and the USA is the first country in the world where the agent has been launched. Eisai has previously said it believes this drug could generate sales of 30 billion yen ($252 million) by fiscal 2020. Eisai must now aim to expand the drug’s use beyond the relatively small indication of radioactive iodine-refractory differentiated thyroid cancer, commented analysts at EP Vantage at the time of the US approval.

Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs. The number of patients newly diagnosed with thyroid cancer in 2012 in the USA was estimated to be approximately 52,000.

Under review in Japan and EU, as well as elsewhere

Currently the agent is undergoing regulatory review in Japan and the European, as well as Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil, and Lenvima was also granted accelerated assessment in the EU. Eisai will continue to file applications seeking regulatory approval for the agent in countries around the world, and the company will market the agent in those countries where approval has been received. Furthermore, Eisai is conducting a global Phase III trial of Lenvima in hepatocellular carcinoma as well as Phase II studies of Lenvima in several other tumor types such as renal cell carcinoma and non-small cell lung cancer.

Eisai is planning further late-stage trials in liver, kidney, lung and endometrial cancers, and, if these prove fruitful, lenvatinib could gross more than $1 billion a year by 2020, Eisai vice president Ivan Cheung recently told the Wall Street Journal.