Eisai’s Thyroid Cancer Drug Receives Early FDA Approval

The US Food and Drug Administration (FDA) has granted an early approval to Eisai’s drug for the most common form of thyroid cancer.

The agency announced that it has approved the Japanese drugmaker’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). The drug won approval a full two months ahead of its already accelerated schedule and a day after detailed results were published in theNew England Journal of Medicine (NEJM).

DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. The National Cancer Institute (NCI) estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014.

Lenvima is a tyrosine kinase receptor inhibitor that blocks the growth agents tumors need to grow and divide. The drug was reviewed under the FDA’s priority review program. Additionally, Lenvima was granted orphan product designation from the agency, since it is intended to treat a rare disease.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

The approval was based on data from a late-stage trial, which showed that the drug significantly improved progression-free survival (PFS) and overall response rate in this patient population

Earlier this week, an Eisai executive told the Wall Street Journal that the drug is expected to gross $1 billion per year by 2020. In addition to DTC, the company is also testing the drug for treatment of patients with hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and endometrial cancer.

Source: US Food and Drug Administration

Last updated: 2/13/15; 10:55am EST

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