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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
How does Opdivo (nivolumab) work?
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.
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Is Opdivo (nivolumab) approved?
- FDA (USA)
- December 22, 2014, for unresectable or metastatic melanoma
- March 4, 2015, for metastatic squamous non-small cell lung cancer (NSCLC)
- November 23, 2015, for advanced renal cell carcinoma
- May 17, 2016, for classical Hodgkin lymphoma (cHL)
- November 10, 2016, for head and neck squamous cell carcinoma (HNSCC)
- February 2, 2017, for advanced unresectable or metastatic urothelial carcinoma
- August 1, 2017, for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer
- September 22, 2017, for hepatocellular carcinoma (HCC) following prior treatment with sorafenib14
- 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 resection
- EMA (EU)
- June 19, 2015, for metastatic melanoma
- July 20, 2015, for NSCLC6
- February 26, 2016, for advanced renal cell carcinoma
- October 13, 2016, for relapsed or refractory cHL
- June 2, 2017, for urothelial carcinoma
- TGA (Australia)
- January 11, 2016, for the metastatic melanoma and NSCLC3, and later for advanced clear cell renal cell and relapsed or refractory cHL.
- PMDA (Japan)
- June 2014 for unresectable malignant melanoma
- December 17, 2015, for NSCLC
- August 5, 2016, for unresectable or metastatic renal cell carcinoma
- October 17, 2016, for relapsed or refractory classical Hodgkin lymphoma
- February 22, 2017, for recurrent or distant metastatic head and neck cancer
- 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.
Note: Consult your treating doctor for personalized dosing.
Are there any known adverse reactions of Opdivo (nivolumab)?
Common adverse reactions
The most common adverse reactions were:
- musculoskeletal pain
- Read more
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