FDA Expands Use for Anticancer Therapeutic

The U.S. Food and Drug Administration approval provides a new option for patients with the most common type of kidney cancer

The U.S. Food and Drug Administration (FDA) recently added lenvatinib (Lenvima) to the armamentarium for oncologists treating certain patients with the most common form of kidney cancer diagnosed in U.S. adults – renal cell carcinoma.

Lenvatinib is intended for use in combination with everolimus (Afinitor) for treating patients with advanced renal cell carcinoma that has progressed despite treatment with at least one other antiangiogenic therapeutic, a type of anticancer agent that prevents tumors from establishing the blood and lymphatic vessel networks they need to grow and survive. The combination improved progression-free survival for patients compared with everolimus alone.

This is the second antiangiogenic therapeutic in a short space of time 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. The other, cabozantinib (Cabometyx), was approved for treating this group of patients in late April 2016. Five other antiangiogenic therapeutics are approved as the initial treatment for patients with advanced renal cell carcinoma.

Antiangiogenic therapeutics target a combination of the many molecules that promote new blood and lymphatic vessel growth within a tumor. In many cases, they also target 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. Therefore, 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. 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

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.

The FDA approval was rendered on April 11, 2016.