Lenvima, a cancer medicine taken by mouth, has been shown in studies to extend progression-free survival (PFS) in kidney, liver, thyroid and endometrial cancer. In these various types of cancer, PFS has ranged from a median of 7.3 months to 23.9 months, depending upon use.

PFS is the length of time during and after cancer treatment that a patient lives with the disease but it does not get worse.

Lenvima may also be given in addition to other treatments such as everolimus (Afinitor) or pembrolizumab (Keytruda).

View study results with Lenvima here.

What does Lenvima treat?

Lenvima (lenvatinib) is an oral prescription medicine approved by the FDA for the treatment of:

• thyroid cancer usually given after radioactive iodine has been tried without success
• advanced renal cell carcinoma (kidney cancer): in combination with everolimus (Afinitor), following at least one other therapy that did not work; OR with pembrolizumab (Keytruda) as a first-line (initial) treatment
• inoperable hepatocellular (liver) carcinoma (HCC) as a first-line treatment
• certain types of advanced endometrial cancer, in combination with pembrolizumab (Keytruda), in patients whose disease has progressed after other therapy and they cannot have surgery or radiation.

Lenvima is a kinase inhibitor that blocks certain endothelial growth factor (VEGF) receptors. It works by blocking the signals directed at blood vessels to help slow down the growth and spread of certain types of cancer.

How will I take Lenvima?

Lenvima is taken as a an oral capsule once a day, with or without food, at the same time each day. Take it exactly as prescribed by your healthcare provider.

• You should take Lenvima every day unless otherwise instructed by your doctor.
• You will take Lenvima until your body no longer responds to the treatment or the side effects become too severe for you to tolerate.

How effective is Lenvima for cancer in studies?

Thyroid cancer: Lenvima vs. placebo

In Feb. 2015, the FDA approved Lenvima to treat thyroid cancer. Lenvima was studied in 392 patients for the treatment of differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing. Patients received either Lenvima or a placebo (inactive) treatment during the study.

• In the SELECT study, statistically significant results showed that half of the Lenvima-treated patients lived longer than 18.3 months without their disease progressing (median of 18.3 months of progression-free survival, PFS), compared to a median of 3.6 months for participants who received a placebo (an inactive treatment).
• Additionally, 65% of patients treated with Lenvima saw a reduction in tumor size, compared to the 2% of participants who received a placebo.

Progression-free survival (PFS) is the length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse.

Advanced renal (kidney) cell cancer: Lenvima + Keytruda vs. sunitinib

Lenvima is used in combination with Keytruda (pembrolizumab) to treat adults with advanced renal cell carcinoma (a type of kidney cancer) as an initial (first-line) treatment. The use was approved by the FDA in August 2021.

In the Phase 3 CLEAR/KEYNOTE-581 trial, when Lenvima was given with Keytruda in patients with advanced renal cell cancer, this study showed a significant improvement when compared to Sutent (sunitinib) on progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR).

• For progression-free survival (PFS), Keytruda plus Lenvima reduced the risk of disease progression or death by 61% with a median PFS of 23.9 months versus 9.2 months for sunitinib.
• For overall survival (OS), Keytruda plus Lenvima reduced the risk of death by 34% when compared to sunitinib.
• The objective response rate (ORR) was 71% (complete response (CR) rate of 16% and partial response (PR) rate of 55%) for patients who received Keytruda plus Lenvima versus 36% (a CR rate of 4% and a PR rate of 32%) with sunitinib.

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Advanced renal (kidney) cell cancer: Lenvima + everolimus vs. everolimus

Lenvima is also used in combination with everolimus to treat adults with advanced renal cell carcinoma following one prior treatment called antiangiogenic therapy, another type of cancer-fighting medicine. This indication was cleared by the FDA in May 2016.

In studies, when Lenvima plus Afinitor (everolimus) were given together in patients with renal cell cancer, the results showed a median progression-free survival (PFS) of nearly 3 times that of everolimus when given alone.

• The median PFS, the length of time from study entry until disease progression or death, was 14.6 months for the combined treatment compared with 5.5 months with everolimus alone.
• Lenvima plus everolimus resulted in a 63% reduction in the risk of disease progression or death compared with everolimus alone.

Hepatocellular (liver) cancer: Lenvima vs. sorafeni

In August 2018, the FDA cleared Lenvima for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be fully removed with surgery.

Approval was based on a Phase 3 study against an active comparator (sorafenib, brand name: Nexavar) in unresectable hepatocellular carcinoma.

• In the REFLECT Phase 3 study, treatment with Lenvima was shown to be no worse than treatment with sorafenib (noninferior) with a median overall survival of 13.6 months versus 12.3 months with sorafenib.
• In addition, the median progression-free survival (PFS) was doubled with Lenvima compared to sorafenib: 7.3 months versus 3.6 months, respectively.
• Lenvima also demonstrated over 3 times the objective response rate (ORR) of sorafenib: 41% vs. 12%, respectively.

Endometrial cancer: Lenvima plus Keytruda (pembrolizumab) vs. chemotherapy

In July 2021, the FDA approved Lenvima plus Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma (EC) that IS mismatch repair proficient (pMMR), as determined by an FDA-approved test, or NOT microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

In this study, medication included:

• Lenvima 20 mg orally once daily in combination with pembrolizumab 200 mg intravenously every 3 weeks, OR
• Investigator’s chemotherapy choice, consisting of either doxorubicin or paclitaxel.

The approval was based on the Phase 3 KEYNOTE-775/Study 309 study.

• In the study, Lenvima plus Keytruda showed significant improvements in overall survival (OS), reducing the risk of death by 32% compared to select chemotherapy treatment.
• The median progression-free survival (PFS) was 6.6 months with Lenvima + Keytruda compared to 3.8 months for chemotherapy.
• Progression-free survival (PFS) showed a significant reduction in the risk of disease progression or death by 40% (hazard ratio) versus chemotherapy.
• There was also a significant improvement in objective response rate (ORR) of 30% for Lenvima + Keytruda compared to 15% for patients who received chemotherapy.

Related: How long do you take Lenvima?

This is not all the information you need to know about Lenvima (lenvatinib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

• Lenvima (lenvatinib) prescribing information. Drugs @ FDA. Eisai Inc. Nutley, NJ. Revised Nov. 2022. Accessed Sep 11, 2023 at  https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf
• FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC). Drugs.com. August 11, 2021. Accessed Sep 11, 2023 at https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-plus-lenvima-lenvatinib-combination-first-line-adult-patients-5631.html
• FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC). Drugs.com. August 16, 2018. Accessed Sep 11, 2023 at https://www.drugs.com/newdrugs/fda-approves-lenvima-lenvatinib-first-line-unresectable-hepatocellular-carcinoma-hcc-4799.html
• FDA Approves Lenvima (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma. Drugs.com. May 13, 2016. Accessed Sep 11, 2023 at https://www.drugs.com/newdrugs/fda-approves-lenvima-lenvatinib-patients-advanced-renal-cell-carcinoma-4382.html
• FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer. Drugs.com. Feb 13, 2015. Accessed Sep 11, 2023 at https://www.drugs.com/newdrugs/fda-approves-lenvima-lenvatinib-differentiated-thyroid-cancer-4164.html
• FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma. Drugs.com. Sep 17, 2019. Accessed Sep 11, 2023 at https://www.drugs.com/newdrugs/fda-approves-keytruda-pembrolizumab-plus-lenvima-lenvatinib-combination-patients-certain-types-5056.html

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Drug information

• Lenvima Information for Consumers
• Lenvima prescribing info & package insert (for Health Professionals)
• Side Effects of Lenvima (detailed)
• Lenvima user reviews (4)

Related support groups

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