FDA approves Keytruda plus Lenvima for advanced kidney cancer

The US Food and Drug Administration (FDA) has approved a combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma – a type of kidney cancer (RCC).

In the the Phase III CLEAR/KEYNOTE-581 trial, Lenvima plus Keytruda reduced the risk of disease progression or death by 61%. For overall survival, Lenvima plus Keytruda reduced the risk of death by 34% versus Pfizer’s Sutent (sunitinib).

Gregory Lubiniecki, vice president, oncology clinical research, MSD, said: "We are focused on delivering meaningful innovations that extend the lives of people with cancer. We are proud to see how our collaboration with Eisai can now help to improve survival outcomes for patients with advanced renal cell carcinoma and are committed to further exploring Keytruda plus Lenvima in other difficult-to-treat cancers."

This approval was reviewed under the FDA's Real-Time Oncology Review (RTOR) pilot programme – a scheme which aims to improve the efficiency of the review process for applications to ensure that new treatments are available to patients as early as possible.