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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma¹

Published: 2023-10-14 01:18:00 ET

In the Phase 3 CheckMate -76K trial, Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared to placebo1

CheckMate -76K marks the fifth Opdivo-based indication in earlier stages of cancer, in the U.S.1

Opdivo is the only PD-1 inhibitor that is indicated as an adjuvant treatment for eligible patients with stages IIB, IIC, III, as well as stage IV completely resected melanoma1

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients.1 The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).1,2

In the trial, Opdivo reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI]: 0.30-0.59; P

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.