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# FDA OK’s Combo Drugs for Kidney Cancer
- URL: https://www.fdaweb.com/fda-oks-combo-drugs-for-kidney-cancer/
- Published: 2019-05-16T12:00:00.000Z
- Updated: 2026-09-15T01:27:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144124

FDA has approved an EMD Serono and Pfizer NDA for Bavencio (avelumab) in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC, the companies say. Approval was based on data from the Phase 3 JAVELIN Renal 101 study ([NCT02684006](https://c212.net/c/link/?t=0&l=en&o=2455068-1&h=451911890&u=https%3A%2F%2Fclinicaltrials.gov%2Fshow%2FNCT02684006&a=NCT02684006&ref=fdaweb.com)), in which the combination significantly improved median progression-free survival compared with sunitinib by more than five months in the intent-to-treat patient population.

RCC is a type of cancer where PD-L1 expression may contribute to inhibition of the immune response against the tumor, the companies say. It is also a highly vascular tumor, in which vascular endothelial growth factor plays a key role.