Benzinga | Nov 18, 2021 09:53AM EST

Merck's Keytruda Scores First Approval In Adjuvant Kidney Cancer Setting

* The FDA has approved Merck & Co Inc's (NYSE:MRK) Keytruda, an anti-PD-1 therapy, for the adjuvant treatment of renal cell carcinoma (RCC).

* The news comes almost half a year after Merck took the stage at ASCO to report Phase 3 data showing Keytruda cut the risk of cancer relapse or death by 32% compared to placebo, hitting the primary endpoint of disease-free survival.

* The study, dubbed KEYNOTE-564, enrolled 994 RCC patients at intermediate-high or high risk of recurrence after a kidney removal or after removal of a kidney and metastatic lesions.

* The trial will continue to assess overall survival (OS) as a secondary outcome measure.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: MRK shares are down 0.06% at $82.55 during the market session on the last check Thursday.