FDA Approval: Lenvatinib (Lenvima) for Thyroid Cancer

The problem this drug was approved to solve

Most thyroid cancer is easy to treat. NCI notes that the well-differentiated types, papillary and follicular thyroid cancer, can usually be cured. The standard tools are surgery and then radioactive iodine, a treatment swallowed as a capsule or liquid that thyroid cells soak up and that destroys them from the inside.

The trouble comes when a cancer stops soaking it up. Doctors call that radioactive iodine-refractory disease. If such a cancer has also spread or come back, the usual toolkit is gone.

That is the exact gap the FDA filled on 13 February 2015, when it approved lenvatinib, sold as Lenvima, under application NDA 206947 from Eisai.

What lenvatinib does

Lenvatinib is a multikinase inhibitor. Kinases are switch-like proteins inside cells that pass along growth signals; a kinase inhibitor jams several of those switches at once.

NCI describes the drug as blocking the development of new tumor blood vessels and blocking specific proteins that signal thyroid cancer cells to grow and divide. Starving a tumor of new vessels is called antiangiogenic treatment. It is a different idea from chemotherapy, which attacks dividing cells directly. Our overview of targeted therapy explains the family this drug belongs to.

The trial behind the decision

The FDA's own published approval summary describes an international, double-blinded, placebo-controlled trial in 392 people with locally recurrent or metastatic radioactive iodine-refractory differentiated thyroid cancer, all with imaging proof that the disease had grown in the previous 12 months.

They were assigned 2 to 1: 261 to lenvatinib at 24 mg by mouth daily, 131 to a matching placebo. People on placebo could switch to lenvatinib if independent review confirmed their cancer had grown. That starting amount was fixed for the trial. In practice it is often reduced, so go by your own prescription.

Median progression-free survival, meaning the time before the cancer grew again or the person died, was 18.3 months with lenvatinib and 3.6 months with placebo. The hazard ratio was 0.21, with a 95% confidence interval of 0.16 to 0.28. NCI adds that tumors shrank in 65% of the lenvatinib group against 2% of the placebo group.

The cost side of the ledger

The same FDA summary is candid about tolerability. The most common side effects, in order, were high blood pressure, fatigue, diarrhea, joint and muscle pain, reduced appetite, weight loss, nausea, mouth sores, headache, vomiting, protein in the urine, hand-foot skin reaction, abdominal pain and hoarseness.

Side effects forced a dose reduction in 68% of people taking the 24 mg dose, and 18% stopped the drug because of them. The FDA authors wrote that this leaves real uncertainty about the best dose.

Given how often the amount had to be lowered, treat the trial figure as a starting point only. Your own endocrine or oncology team decides what you take.

Where thyroid cancer sits overall

The American Cancer Society projects 45,240 new US thyroid cancer diagnoses and 2,320 deaths in 2026; SEER reports those projections alongside its own measurements. Five-year relative survival across all stages, for 2016 to 2022, is 98.3%.

By stage, among people diagnosed between 2016 and 2022: 99.9% for localized disease, still confined to the thyroid; 98.1% for regional disease, in nearby structures or lymph nodes; and 48.3% for distant disease. Only 3% of cases are distant at diagnosis. Those are group figures across many people and years, not a prediction for any one person. Lenvatinib was approved for a small, difficult slice of that last group.

When to get checked

NCI notes thyroid cancer often causes no early symptoms and is sometimes found during a routine exam. Bring these to a doctor:

• A lump, called a nodule, in the neck
• Trouble breathing
• Trouble swallowing, or pain when swallowing
• Hoarseness that does not settle

Most thyroid nodules are not cancer. The usual next steps are an ultrasound and, if needed, a fine-needle aspiration biopsy, in which a thin needle draws out cells for a pathologist to examine. Our page on thyroid cancer covers the types and what the results mean.

What this does not mean

• The trial measured time without the cancer growing. It was not designed to show that people lived longer overall.
• Approval covers a specific group: differentiated thyroid cancer that has progressed and no longer responds to radioactive iodine. Most thyroid cancer never reaches that point.
• The dose most people ended up taking was lower than the dose studied, and the FDA said so in print.
• Labels change as new data arrive. The current prescribing information on DailyMed is the authority, not this page.

Sources

• NCI, FDA Approves Lenvatinib for Radioactive Iodine-Refractory Thyroid Cancer — https://www.cancer.gov/news-events/cancer-currents-blog/2015/fda-approves-lenvima
• Clinical Cancer Research (record via PubMed), FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer — https://pubmed.ncbi.nlm.nih.gov/26324740/
• FDA Drugs@FDA (openFDA API), LENVIMA NDA 206947, original approval 13 February 2015 — https://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:%22LENVIMA%22
• DailyMed, LENVIMA (lenvatinib) label — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4bedd21-efde-44c6-9d9c-b48b78d7ed1e
• NCI, Lenvatinib Mesylate — https://www.cancer.gov/about-cancer/treatment/drugs/lenvatinibmesylate
• NCI PDQ, Thyroid Cancer Treatment (Patient Version) — https://www.cancer.gov/types/thyroid/patient/thyroid-treatment-pdq
• SEER Cancer Stat Facts, Thyroid Cancer — https://seer.cancer.gov/statfacts/html/thyro.html

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.

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