Drug Approvals

Keytruda, Pfizer combo gets FDA ok for advanced kidney cancer

Apr 22, 2019

The U.S. FDA approved Merck's blockbuster Keytruda in combination with Pfizer's Inlyta as a first-line treatment for advanced renal call carcinoma — kidney cancer that has spread, despite earlier treatments.

This latest FDA approval marks the first for Keytruda in advanced renal cell carcinoma, with previous approvals in skin, lung, cervical, and gastric cancers.

The approval is based on findings from the pivotal Phase 3 trial, which demonstrated significant improvements in overall survival, progression-free survival and objective response rate for the Keytruda-axitinib combo, when compared to sunitinib — a Pfizer drug that is the standard of care for kidney cancer.

Read the press release