FDA Approves Eisai’s LENVIMA (lenvatinib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Eisai is pleased to announce that LENVIMATM (lenvatinib)is now approved for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).

The incidence of thyroid cancer has steadily increased globally over the last 50 years, and as the most common endocrine malignancy, there remains a need for additional treatment options, particularly for patients with DTC whose cancer no longer responds to radioactive iodine (RAI) therapy.The most common types of thyroid cancer, papillary and follicular, are classified as differentiated thyroid cancer (DTC) and account for approximately 90 percent of all cases.

While most patients with DTC are curable with surgery and radioactive iodine treatment, these treatments aren’t effective for some and the prognosis for those patients whose cancers persist or recur is poor. The safety and efficacy of LENVIMA was evaluated in a pivotal clinical trial involving 392 RAI-R DTC patients with radiographic evidence of disease progression within 12 months prior to randomization. The clinical trial showed that patients treated with LENVIMA had a statistically significant prolongation in progression-free survival compared to those receiving placebo.The most common adverse reactions observed in greater than or equal to 30% of LENVIMA-treated patients, in order of decreasing frequency, were: hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, and dysphonia.

We are pleased to be able to offer an additional treatment option to appropriate patients with locally recurrent or metastatic, progressive, RAI-R DTC. At Eisai, our human health care mission to give first thought to patients and families is the driving force behind our commitment to help increase the benefits health care provides to patients, especially those whose diseases have limited treatment options.

As such, Eisai is committed to ensuring patients have access to medicines from which they may benefit and is dedicated to working to ensure that our products are available to those who need them. Patients can visit www.LenvimaReimbursement.com and www.LenvimaSavingsProgram.com to learn more about Eisai’s services and reimbursement support programs.

We thank you for your continued support and commitment to patients suffering from locally recurrent or metastatic, progressive, RAI-refractory DTC and their families. We hope you will share this important news with your constituents.

Indication

LENVIMA (lenvatinib) is indicated for the treatment of patients with locally recurrent, or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

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