FDA approves Merck’s Keytruda combo as kidney cancer treatment

Merck and Eisai add potent new weapon to the pharma battle for kidney cancer supremacy.

On Wednesday, the Food and Drug Administration (FDA) approved a combination of Merck & Co. and Eisai drugs that were shown in clinical testing to delay the progression of advanced kidney cancer and extend survival for patients when used as first-line therapy. It’s the fifth FDA approval for an immunotherapy regimen in front-line kidney cancer, a group that also includes drugs from Bristol Myers, Exelixis, Pfizer and Merck KGaA. Keytruda, a Merck product is already the company’s star drug, with sales up 23% to $4.2 billion in the second quarter on a year-on-year basis. The product is an infusion which works by accelerating the immune system. Lenvima on the other hand is an Eisai drug, a capsule which works by targeting proteins on cancer cells that help tumors spread.


The approval marks the second indication for the pairing following an accelerated approval in endometrial cancer back in 2019 that has since been converted into a full FDA approval. The most recent approval was based on a three-arm study called CLEAR. The trial compared patients who received the Keytruda-Lenvima combination with patients who received Lenvima and a drug called everolimus, as well as patients who received an earlier drug called sunitinib, authorized in 2006 for advanced kidney cancer sold by Pfizer as Sutent. The Keytruda-Lenvima group showed the biggest benefit. The study showed the combo reduced the risk of death or disease progression by 61 % when compared to Sutent. While the pair's recent approval shifts the competition's balance away from other rivals, it's possible that Pfizer stands to lose the most.