Indications

Prescribing Information

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Potential OPDIVO® (nivolumab) user taking a selfie with his son.
Potential OPDIVO® (nivolumab) user taking a selfie with his son.

Clinical trial results for
advanced melanoma

For adults and children 12 years of age and older with melanoma that has spread or cannot be removed by surgery (advanced melanoma)

Actor portrayals.
OPDIVO is not approved for people
younger than 12 years of age.

An FDA-approved immunotherapy that helped people live longer compared to YERVOY alone

About the clinical trial

In a clinical trial of 945 people with previously untreated advanced melanoma, 314 people were given OPDIVO + YERVOY, 316 people were given OPDIVO alone, and 315 people were given YERVOY alone. While your doctor may test you for the BRAF biomarker to help you consider your treatment options, OPDIVO is FDA approved to treat advanced melanoma regardless of your test results.

More people given OPDIVO were alive compared to YERVOY alone at the primary analysis with a minimum follow-up of 28 months

55% of those given OPDIVO® for advanced melanoma survived, versus 37% of those given YERVOY® alone.

In the clinical trial, people given OPDIVO had a 37% lower risk of dying than those given YERVOY alone.

People given OPDIVO lived longer without their cancer spreading, growing, or getting worse compared to YERVOY alone at the primary analysis with a minimum follow-up of 9 months

At 7 months, half the people given OPDIVO® were alive.
OPDIVO

Half the people went without their cancer spreading, growing, or getting worse

At 3 months, half the people given YERVOY® alone were alive.
YERVOY alone

Half the people went without their cancer spreading, growing, or getting worse

In the clinical trial, people given OPDIVO had a 43% lower risk of their cancer spreading, growing, or getting worse than those given YERVOY alone.

More people given OPDIVO saw their tumors shrink or disappear completely compared to YERVOY alone at the primary analysis with a minimum follow-up of 9 months

OPDIVO

YERVOY alone

Tumors disappeared completely (complete response)

9% saw a complete response to OPDIVO® compared to 2% in response to YERVOY® alone for advanced melanoma.

Tumors shrank
(partial response)

31% saw tumors shrink (partial response) from OPDIVO® compared to 12 % in response to YERVOY® alone for advanced melanoma.

Tumors shrank or disappeared completely (overall response)

40% given OPDIVO® saw an overall response to treatment compared to compared to 14% given YERVOY® alone for advanced melanoma.

Words to know

Overall response rate is the percentage of patients who responded to treatment. These patients saw their tumors either shrink or disappear completely.

Partial response is when a tumor reacts to treatment and shrinks.

Complete response is when a tumor reacts to treatment and disappears completely. This is the disappearance of any measurable tumors in response to treatment. This does not mean the cancer has been cured.

OPDIVO will not work for everyone. Individual results may vary.

Hands exploring how OPDIVO® (nivolumab) works and learning how this treatment may help fight cancer.

How treatment works

See how this treatment may help your body fight cancer

OPDIVO® (nivolumab) side effects.

Side effects

View side effects of treatment and learn how to manage them

Nurse monitoring a gentleman's infusion of OPDIVO® (nivolumab) immunotherapy treatment.

Getting an infusion

See your recommended treatment plan and what to expect from an infusion

For adults and children 12 years of age and older with advanced melanoma

OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.



466-US-2400051   04/24