Opdivo (Nivolumab) 40 mg/4 mL

Opdivo (Nivolumab) 40 mg/4 mL

Opdivo (Nivolumab) 40 mg/4 mL is indicated for the treatment of patients with:

• metastatic melanoma as a single agent or in combination with ipilimumab
• metastatic non-small cell lung cancer (NSCLC) whose cancer progressed on or after chemotherapy
• advanced renal cell carcinoma who have received prior anti-angiogenic therap
• classical Hodgkin lymphoma that has relapsed or progressed after other treatments
• recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or within 6 months of receiving platinum-based chemotherapy
• locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy
• microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
• hepatocellular carcinoma in patients who have been previously treated with sorafenib
• for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

How does Opdivo (nivolumab) work?

Opdivo (Nivolumab) 40 mg/4 mL has been designed to attach to a receptor called PD-1, found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor, switching off the T cells. By attaching to the receptor, nivolumab prevents cancer cells from switching off T cells, thereby increasing the ability of the immune system to kill cancer cells

Is Opdivo (nivolumab) approved?

Opdivo (nivolumab) was approved by

• PMDA (Japan)
  • on June 2014 for unresectable malignant melanoma
  • on December 17, 2015, for NSCLC
  • on August 5, 2016, for unresectable or metastatic renal cell carcinoma
  • on October 17, 2016, for relapsed or refractory classical Hodgkin lymphoma
  • on February 22, 2017, for recurrent or distant metastatic head and neck cancer
  • on August 22, 2017, for unresectable advanced or recurrent gastric cancer that has progressed after cancer chemotherapy
  • May 27, 2021, for unresectable advanced or recurrent malignant pleural mesothelioma.
• FDA (USA)
  • on December 22, 2014, for unresectable or metastatic melanoma
  • on May 20, 2021 as adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer
  • EMA (EU)
    • on June 19, 2015, for metastatic melanoma
    • on July 20, 2015, for NSCLC
    • on February 26, 2016, for advanced renal cell carcinoma
• Health Canada on September 25, 2015 for:
  • previously untreated unresectable or metastatic BRAF V600 wild-type melanoma
  • unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
  • melanoma with regional lymph node involvement, in transit metastases/satellites without metastatic nodes, or
• TGA (Australia)
  • on January 11, 2016, for the metastatic melanoma and NSCLC and later for advanced clear cell renal cell and relapsed or refractory cHL.

Are there any known adverse reactions of Opdivo (nivolumab)?

Common adverse reactions

The most common adverse reactions were

• fatigue
• rash
• musculoskeletal pain
• diarrhoea
• nausea.