Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 12, 2019

Avelumab with axitinib

(Bavencio, Axitinib—EMD Serono, Pfizer)
Agent approved for first-line treatment of patients with advanced renal cell carcinoma

EMD Serono and Pfizer announced FDA approval of avelumab in combination with axitinib for 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.

Approval for this indication was based on positive results from the Phase III JAVELIN Renal 101 study, in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than 5 months in the intent-to-treat (ITT) patient population. The ITT population included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62%, and poor 16%)

Common adverse reactions include diarrhea (62% vs. 48%), fatigue (53% vs. 54%), hypertension (50% vs. 36%), musculoskeletal pain (40% vs. 33%), and nausea (34% vs. 39%).