The United States Food and Drug Administration (FDA) has approved Lenvima® (lenvatinib) for the treatment of kidney cancer. The approval is for patients with advanced renal cell carcinoma who have received at least one prior therapy with an anti-angiogenic agent, and is to be used in combination with the standard agent Afinitor® (everolimus).
Each year in the United States, more than 61,000 people are diagnosed with kidney cancer. The most common type of kidney cancer is renal cell carcinoma (RCC), which starts in the lining of very small tubes (tubules) in the kidney.
For people with advanced or metastatic RCC (cancer that has spread to other parts of the body), targeted therapies can play an important role in treatment. Approximately 20-30% of patients with RCC will have metastases at diagnosis and as many as 40% will demonstrate metastasis after treatment for earlier stage RCC. With a 5-year survival rate ranging from 5-10% for patients with advanced RCC, the overall prognosis for these patients is poor with standard therapeutic approaches.
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that that stops or decreases the action of many different cellular processes involved in cancer growth or spread. Lenvatinib is thought to inhibit or decrease the action of VEGFR1 (FLT1), VEGFR2 (KDR), VEGFR3 (FLT4); FGFR1, 2, 3, and 4; PDGFRα, KIT, and RET. Lenvatinib is already approved for the treatment of a type of thyroid cancer.
The recent approval of lenvatinib was based on a trial including approximately 100 patients with advanced RCC who had received prior therapy with anti-angiogenic therapy. In the trial, referred to as Study 205, one group of patients was treated with lenvatinib plus everolimus, and the other group was treated with everolimus only.
- The median time until cancer progression or death was 14.6 months among patients treated with lenvatinib plus everolimus, compared with only 5.5 months among patients treated with everolimus only.
- Anti-cancer responses were achieved in 37% of patients treated with lenvatinib plus everolimus, compared with only 6% of patients treated with everolimus ony.
- Median overall survival was over two years (25.5 months) for the patients treated with lenvatinib/everolimus, compared with only 15.4 months for those treated with everolimus only.
- Some of the most severe side effects associated with lenvatinib/everolimus include high blood pressure, blood clots, heart, and liver problems.
The approval of lenvatinib for the treatment of advanced RCC provides an effective treatment option for patients with this disease. Importantly, both time to cancer progression and overall survival were significantly improved with the addition of lenvatinib to everolimus, compared to everolimus only.
Patients with advanced RCC may wish to speak with their healthcare provider regarding their individual risks and benefits of lenvatinib.
Reference: Eisai. Press Release. FDA approves Eisai’s Lenvima® (lenvatinib) for the treatment of patients with advanced renal cell carcinoma in combination with everolimus following prior anti-angiogenic therapy. Available at: http://eisai.mediaroom.com/2016-05-13-FDA-Approves-Eisais-LENVIMA-lenvatinib-for-the-Treatment-of-Patients-with-Advanced-Renal-Cell-Carcinoma-in-Combination-with-Everolimus-Following-Prior-Anti-Angiogenic-Therapy. Accessed May 16, 2016.
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