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Eisai given early approval for new oncology drug

Japanese firm’s thyroid cancer treatment Lenvimaset to be a blockbuster
Eisai headquarters

Eisai has been given FDA approval for its new oncology medicine Lenvima two months earlier than scheduled thanks to the regulator's fast track system.

Lenvima (lenvatinib) now has a US licence to treat progressive, differentiated thyroid cancer (DTC) in patients that have not responded to radioactive iodine therapy.

DTC is a cancerous growth of the thyroid gland, which is located in the neck, and helps regulate metabolism.

Eisai is also testing the drug in a number of other cancers and analysts expect the treatment to reach more than $1bn in sales at its peak in 2020.

The US regulator had assessed the drug under its priority review programme which speeds up its evaluation process for new medicines that can treat an unmet medical need.

The FDA was slated to make a decision on Lenvima by April 14 but managed to make its decision more than two months early.

Richard Pazdur, director of the office of haematology and oncology products at the FDA, said: “The development of new therapies to assist patients with refractory disease is of high importance to the FDA.

“This approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

Data for the drug showed patients on Lenvima lived a median of 18.3 months without their disease progressing (progression-free survival), compared to a median of 3.6 months for patients who received a placebo.

Lenvima works as a kinase inhibitor and blocks certain proteins from helping cancer cells grow and divide.

Until recently, there have been few drugs for thyroid cancer, but in the past two years a number of new therapies have been approved.

In 2012 the EMA gave the green light to AstraZeneca's Caprelsa (vandetanib), although this is for a different form of the disease, specifically for the treatment of aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

And in 2013 the FDA approved a licence extension for Bayer's liver and kidney cancer medicine Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.

Last year, about 62,980 Americans were diagnosed with thyroid cancer, and at least 1,890 succumbed to the disease, according to the National Cancer Institute.

Article by
Ben Adams

16th February 2015

From: Sales



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