Nivolumab is the first PD-1 inhibitor to be given the go ahead by the US FDA as an adjuvant therapy for patients with urothelial carcinoma at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or programmed death-ligand 1 (PD-L1). This approval is based on the results from the phase III CheckMate-274 trial, in which nivolumab almost doubled the post-surgery median disease-free survival compared to placebo; 20.8 months versus 10.8 months, respectively. This amounts to a 30% decrease in the risk for disease recurrence or death.

Dose and administration: 240 mg every 2 weeks or 480 mg every 4 weeks (injection for intravenous use)

Warnings & Precautions: Severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction and other immune-mediated adverse reactions, risk of infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, embryo-fetal toxicity, and increased mortality in myeloma patients when added to a thalidomide analogue and dexamethasone

(Source: Medpage Today, August 20, 2021)