FDA Increases Antiangiogenic Treatment Options for Kidney Cancer

Late last week, the U.S. Food and Drug Administration (FDA) added another antiangiogenic therapeutic to the armamentarium for oncologists treating certain patients with kidney cancer: lenvatinib (Lenvima). Specifically, lenvatinib is intended for use in combination with everolimus (Afinitor) for treating patients with advanced renal cell carcinoma—the most common form of kidney cancer diagnosed in U.S. adults—that has progressed despite treatment with at least one other antiangiogenic therapeutic.

Histopatholgical image of papillary carcinoma of the thyroid gland obtained by a total thyroidectomy.

Histopatholgical image of papillary carcinoma of the thyroid gland obtained by a total thyroidectomy.

This is the second antiangiogenic therapeutic to be approved by the FDA as a treatment option for patients with renal cell carcinoma that has progressed following therapy with at least one prior antiangiogenic agent in just three weeks. As highlighted previously on this blog, the FDA approved cabozantinib (Cabometyx) for treating this group of patients in late April. Five other antiangiogenic therapeutics are approved as the initial treatment for patients with advanced renal cell carcinoma.

Antiangiogenic therapeutics work by impeding the growth of the blood and lymphatic vessel networks that tumors establish to grow and survive. They do this by targeting a combination of the many molecules that promote new blood and lymphatic vessel growth within a tumor.

In many cases, antiangiogenic therapeutics also work by targeting molecules that promote tumor growth and cancer progression in other ways.

Each antiangiogenic therapeutic targets a slightly different combination of molecules, thereby working in slightly different ways. As a result, even if a patient’s tumor develops resistance to one antiangiogenic therapeutic, he or she is often treated with a second member of this class of anticancer therapeutics.

The FDA based its approval of lenvatinib in combination with everolimus for advanced renal cell carcinoma on results from a randomized, phase II clinical trial. Initial results from the trial, published in The Lancet Oncology in November 2015, showed that adding lenvatinib to everolimus more than doubled the time before disease progressed for patients with renal cell carcinoma who had previously been treated with one or more antiangiogenic therapeutic. Specifically, progression-free survival was 14.6 months for the combination arm compared with 5.5 months for the everolimus arm. The FDA announcement stated also that the combination resulted in a 33 percent reduction in the risk for death compared with everolimus alone.

This decision by the FDA expands the number of cancer types for which lenvatinib is approved. As discussed in a prior blog post, the FDA first approved lenvatinib in February 2015 for patients with locally recurrent or metastatic differentiated thyroid cancer that has progressed despite radioactive iodine therapy, like Lori Cuffari, who was featured in the AACR Cancer Progress Report 2015.

Learn more about Lori’s story in this video:

Given that researchers are currently testing the antiangiogenic therapeutic in clinical trials as a potential treatment for a number of other types of cancer, including liver and non–small cell lung cancer, we hope to hear of further expansions in the use of lenvatinib in the future.