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FDA approved Lenvima (lenvatinib) for Radioactive Iodine-Refractory Differentiated Thyroid CancerFDA approved new daily pill for a hard-to-treat thyroid cancer

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Key Takeaway
Consider Lenvima 24 mg daily for radioactive iodine-refractory DTC; monitor for adverse reactions.

The U.S. Food and Drug Administration has approved Lenvima (lenvatinib) for the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). This indication addresses a patient population with limited effective treatment options after standard therapies fail.

Lenvatinib is an oral kinase inhibitor. The recommended dosage for DTC is 24 mg once daily until disease progression or unacceptable toxicity. The label includes dose modifications for adverse reactions and specific guidance for patients with renal or hepatic impairment.

This approval offers a new systemic therapy for clinicians managing progressive, radioactive iodine-refractory DTC. The label does not contain clinical trial efficacy data; therefore, no comparative efficacy or survival outcomes can be reported here.

+ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Lenvatinib is a kinase inhibitor. The exact mechanism of action in DTC is not fully described in the label.

Indication & Patient Population

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

Dosing & Administration

The recommended dosage for DTC is 24 mg orally once daily until disease progression or unacceptable toxicity. Take Lenvima once daily, with or without food, at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time. Reduce the dose for certain patients with renal or hepatic impairment. Dose interruptions, reductions, and discontinuations for adverse reactions are provided in the label.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Specific warnings, precautions, and contraindications are not detailed in the provided label text. Refer to the full prescribing information for complete safety information.

Place in Therapy

Lenvima provides an oral treatment option for adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. It is administered as a single agent. The label does not include data comparing Lenvima to other therapies.

The FDA has approved a new drug called Lenvima, also known as lenvatinib, for adults with a certain kind of thyroid cancer. This cancer is called differentiated thyroid cancer. It has come back in the same area or spread to other parts of the body. It has also stopped responding to radioactive iodine, a common treatment. These patients often have few good treatment choices left.

Lenvima is a pill taken once a day. The usual dose is 24 mg. Patients keep taking it until the cancer gets worse or side effects become too much. The drug works by blocking certain proteins that help cancer cells grow. The label includes ways to lower the dose if needed, and special guidance for people with kidney or liver problems.

This approval offers doctors a new systemic therapy, meaning a drug that travels through the body, for patients with this progressive cancer. It is an important step for a group with limited options.

One honest note: the approval announcement does not include data from clinical trials. So we cannot say how well it works compared to other treatments or whether it helps people live longer. If you or someone you love has this type of thyroid cancer, talk with your doctor. They can help you understand if this drug is right for you.

What this means for you:
New pill approved for advanced thyroid cancer that no longer responds to standard treatment.

Study Details

Study typeFda approval
PublishedFeb 2015
View Original Abstract ↓
1 INDICATIONS AND USAGE LENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). ( 1.1 ) Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. ( 1.2 ) Hepatocellular Carcinoma (HCC) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). ( 1.3 ) Endometrial Carcinoma (EC) In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.4 , 2.1 ) 1.1 Differentiated Thyroid Cancer LENVIMA is indicated for the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). 1.2 Renal Cell Carcinoma LENVIMA, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). LENVIMA, in combination with everolimus, is indicated for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy. 1.3 Hepatocellular Carcinoma LENVIMA is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.4 Endometrial Carcinoma LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration ( 2.1 )] .
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