OPDIVO

What it is

OPDIVO (nivolumab) is a fully human anti-PD-1 monoclonal antibody (IgG4) produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. It is supplied as a 10 mg/mL concentrate solution for infusion.

Approved indications

— Adjuvant treatment of adults and adolescent patients 12 years and older with completely resected Stage IIB, IIC, III or IV melanoma as monotherapy. — Treatment of patients with unresectable or metastatic melanoma as monotherapy. — Treatment of patients with unresectable or metastatic melanoma in combination with ipilimumab. — Neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-doublet chemotherapy. — First-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. — Treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy as monotherapy. — Treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy as monotherapy. — First-line treatment of patients with unresectable malignant pleural mesothelioma in combination with ipilimumab. — Treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma in combination with ipilimumab. — First-line treatment of patients with advanced renal cell carcinoma in combination with cabozantinib. — Treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy as monotherapy. — Treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin as monotherapy. — Treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy as monotherapy. — Adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC as monotherapy. — First-line treatment of patients with unresectable or metastatic urothelial carcinoma in combination with cisplatin and gemcitabine. — Treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy as monotherapy. — First-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma in combination with ipilimumab. — Treatment of patients with hepatocellular carcinoma after prior sorafenib therapy as monotherapy. — First-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1% in combination with ipilimumab. — First-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1% in combination with fluoropyrimidine- and platinum-based combination chemotherapy. — Treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy as monotherapy. — Adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy as monotherapy. — First-line treatment of patients with HER2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-based combination chemotherapy. — Treatment of adult patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR in combination with ipilimumab.

Key safety warnings

Immune-related adverse reactions are seen more frequently, and are more severe, with OPDIVO and ipilimumab combination therapy than with OPDIVO or ipilimumab monotherapy. Immune-related adverse reactions can involve any organ system, with the majority initially manifesting during treatment; however, a minority can occur weeks to months after discontinuation. Some immune-related adverse reactions can be permanent, such as thyroid dysfunction and diabetes mellitus. Life-threatening or fatal immune-related adverse reactions that have occurred include colitis, intestinal perforation, hepatitis, pneumonitis, hypophysitis, adrenal insufficiency, toxic epidermal necrolysis, myocarditis, encephalitis and myasthenia gravis. Early diagnosis and appropriate management are essential to minimise life-threatening complications, with monitoring at least prior to each dose recommended.

PBS listing

OPDIVO 100 mg in 10 mL for intravenous infusion is listed on the PBS with 10 items under authority required (streamlined) restriction, with an ex-manufacturer price of A$1972.83.

Regulatory history

OPDIVO nivolumab 40 mg in 4 mL and 100 mg in 10 mL concentrated solution for intravenous infusion were first listed on the ARTG on 11 January 2016. OPDIVO nivolumab 240 mg in 24 mL concentrate solution for intravenous infusion was first listed on the ARTG on 9 April 2020. In November 2014, the PBAC recommended OPDIVO for treatment of locally advanced or metastatic non-small cell lung cancer in patients who had progressed on or after platinum-containing chemotherapy, and for treatment of unresectable or metastatic melanoma in patients who had progressed on or after prior treatment with ipilimumab. The TGA approved OPDIVO in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer on 17 February 2023.