FDA Approves Opdivo for Adjuvant Treatment of Melanoma

CancerConnect News: The United States Food and Drug Administration granted regular approval to the anti-PD1 monoclonal antibody, Opdivo (nivolumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Opdivo was previously approved for the treatment of patients with unresectable or metastatic melanoma.

Opdivo offers patients a new, improved option to reduce the risk of melanoma returning with fewer side effects than currently available treatments.

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Adjuvant Therapy in Melanoma

Melanoma is separated into five staging categories (stages 0-4).  Stage 3 melanoma is a cancer that has spread to the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized).  Current standard treatment of stage 3 melanoma is surgical resection of the primary tumor as well as the involved lymph nodes. Despite surgical removal of the cancer however, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage IIIb and IIIc patients (68% and 89%, respectively) experience disease recurrence. There remains an unmet need for adjuvant therapy administered following surgery to reduce the risk of the cancer spreading.

About Opdivo

Opdivo is a precision cancer medicine that belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Opdivo works by blocking PD-1. PD-1 inhibitors are being investigated in more than 30 different cancers, and it is already approved for the treatment of melanoma and lung cancer and researchers continue to evaluate its effectiveness in different types of cancer.

The FDA approval of Opdivo in the adjuvant setting is based on results from the CheckMate-238 clinical trial, which had been previously published in the New England Journal of Medicine.2   In this study Opdivo significantly improved recurrence-free survival at 18 months (66%) compared to standard treatment with Yervoy® (ipilimumab), (53%) in patients with resected Stage III or Stage IV melanoma. Opdivo was also associated with fewer serious treatment-related toxicities and adverse events leading to treatment discontinuation (9% vs 42%, respectively).

Keep current about treatment advances in melanoma.


  1. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm590004.htm?utm_campaign=Oncology%2011%2F13&utm_medium=email&utm_source=Eloqua&elqTrackId=5eba2e45eedc41c3ad7ee0d0f384d47d&elq=b14ba5f45b984eceb74815dd4c1b7c5a&elqaid=1865&elqat=1&elqCampaignId=1243
  2. Weber J, Mandala M, Del Vecchio M, et al. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. September 10, 2017DOI: 10.1056/NEJMoa1709030

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