BAVENCIO® (avelumab)—a STANDARD OF CARE in first-line maintenance treatment of locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy1,2
maintenance IO with
NCCN Category 1 and
Preferred status3
demonstrated in the largest
Phase 3 pivotal trial
(N=700), with follow-up
data of 38 months4,8-11
profile; no new safety
signals observed in the
follow-up period4,8
regardless of
cisplatin eligibility3
BAVENCIO warnings and precautions
-
Severe and fatal immune-mediated adverse reactions
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Hepatotoxicity and immune-mediated hepatitis
- Immune-mediated endocrinopathies
- Immune-mediated nephritis with renal dysfunction
- Immune-mediated dermatologic adverse reactions
- Other immune-mediated adverse reactions
- Infusion-related reactions
- Complications of allogeneic hematopoietic stem cell transplantation
- Embryo-fetal toxicity
See Safety Profile for more information on BAVENCIO warnings and precautions.
Most common adverse reactions
The most common adverse reactions (≥20%) in patients receiving BAVENCIO + BSC vs BSC alone were:
- Fatigue (35% vs 13%)
- Musculoskeletal pain (24% vs 15%)
- Urinary tract infection (20% vs 11%)
- Rash (20% vs 2.3%)
BSC=best supportive care; Preferred intervention=Interventions that are based on superior efficacy, safety, and evidence; and,
when appropriate, affordability.
NCCN=National Comprehensive Cancer Network® (NCCN®)