Opdivo (nivolumab)

Description

What is Opdivo (nivolumab) for?

Opdivo (nivolumab) 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 therapy
• 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

How does Opdivo (nivolumab) work?

Opdivo (nivolumab) 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

• FDA (USA)
  • on December 22, 2014, for unresectable or metastatic melanoma
  • on March 4, 2015, for metastatic squamous non-small cell lung cancer (NSCLC)
  • on November 23, 2015, for advanced renal cell carcinoma
  • on May 17, 2016, for classical Hodgkin lymphoma (cHL)
  • on November 10, 2016, for head and neck squamous cell carcinoma (HNSCC)
  • on February 2, 2017, for advanced unresectable or metastatic urothelial carcinoma
  • on August 1, 2017, for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer
  • on September 22, 2017, for hepatocellular carcinoma (HCC) following prior  treatment with sorafenib
  • on December 20, 2017, for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection¹
• EMA (EU)
  • on June 19, 2015, for metastatic melanoma
  • on July 20, 2015, for NSCLC
  • on February 26, 2016, for advanced renal cell carcinoma
  • on October 13, 2016, for relapsed or refractory cHL
  • on June 2, 2017, for urothelial carcinoma
• TGA (Australia)
  • on January 11, 2016, for the metastatic melanoma and NSCLC³, and later for advanced clear cell renal cell and relapsed or refractory cHL.
• 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^.

How do I take Opdivo (nivolumab)?

The recommended therapy varies for the different indications and depends on whether nivolumab is used alone or in combination with other therapeutics. Complete information about nivolumab dosage and administration for some of the countries of approval can be found in the official prescribing information listed in our resources section^.

Note: Consult your treating doctor for personalised dosing.

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

Common adverse reactions

The most common adverse reactions were:

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

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^.

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