Key Points

• You will take Lenvima (lenvatinib) until your body no longer responds to the medication or the side effects become too severe for you to tolerate.
• In safety studies conducted by the manufacturer, most patients took Lenvima for 6 to 16 months for the treatment of various types of cancer. Overall, 18% to 29% of patients had to stop treatment because of side effects they could not tolerate.
• Your Lenvima treatment length will vary based on your cancer type, previous treatments, and tolerability of side effects, among other factors.

Lenvima (levatinib) 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
• inoperable hepatocellular (liver) carcinoma (HCC) as a first treatment
• certain types of 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 taken once a day, with or without food, at the same time each day. You should take Lenvima every day unless otherwise instructed by your healthcare provider.

Lenvima is known as a multiple receptor tyrosine kinase (RTK) inhibitor. It works by blocking certain proteins that increase cancer cell growth. It blocks signals to help slow down the growth of blood vessels that support the tumor's growth.

How long did patients take Lenvima in studies?

In studies looking at the treatment of various cancer types, Lenvima extended the progression-free survival (PFS) time for some patients. PFS is the length of time during and after treatment that patients live without their cancer getting worse when compared to another treatment or a placebo (an inactive treatment).

• The median treatment duration of Lenvima in thyroid cancer studies was 16.1 months. For the treatment of thyroid cancer, Lenvima-treated participants lived a median of 18.3 months without their disease progressing (PFS), compared to a median of 3.6 months for participants who received a placebo.
• The median treatment duration of Lenvima in advanced kidney cancer studies was 16.1 months. In these studies, Lenvima and everolimus together resulted in a median PFS of 14.6 months for the combined treatment compared with 5.5 months in those patients who received everolimus alone.

Lenvima is also approved for the treatment of unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be fully removed with surgery.

• The median treatment duration with Lenvima was at least 6 months in 49% of patients.
• In these studies, Lenvima was shown to be noninferior to (not worse than) sorafenib (Nexavar) with a median overall survival of 13.6 months versus 12.3 months with sorafenib. Overall survival is the length of time from the start of treatment that patients are still alive.

In studies looking at the use of Lenvima plus Keytruda (pembrolizumab) for the treatment of patients with certain types of endometrial cancer, the median duration of study treatment was 7 months long, but ranged up to 37.8 months. Sixty-nine percent of patients with endometrial cancer had a treatment response that lasted at least 6 months.

Do side effects affect treatment time with Lenvima?

Yes, the length of time you take Lenvima may be affected by the number and severity of side effects you experience.

• In treatment of thyroid cancer, 18% of patients permanently discontinued treatment due to severe side effects.
• For kidney cancer, 29% of patients stopped treatment due to side effects.
• In liver cancer studies, 20% of participants withdrew from treatment due to adverse reactions
• In endometrial cancer studies, 21% of patients stopped treatment due to severe side effects. Fatal adverse reactions occurred in 3% of patients.

This is not all the information you need to know about Lenvima (levatinib) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Lenvima information here, and discuss this information and any questions you have with your doctor or other health care provider.