Indications

Prescribing Information

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Potential OPDIVO® (nivolumab) user fishing with his young grandson.
Potential OPDIVO® (nivolumab) user fishing with his young grandson.

Clinical trial results for
previously treated colorectal
cancer (MSI-H/dMMR)

For adults and children 12 years of age and older whose MSI‑H/dMMR colorectal cancer (CRC) has spread to other parts of the body (metastatic) and who have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working

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

An FDA-approved immunotherapy that could make tumors either shrink or disappear completely

About the clinical trial

In a clinical trial, the overall response rate to OPDIVO was looked at in 74 people with MSI-H/dMMR CRC that had spread to other parts of the body and were treated with at least one line of therapy that included fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy.

Of these people, 53 people received prior treatment with all three of the following: fluoropyrimidine, oxaliplatin, and irinotecan.

People saw their tumors shrink or disappear completely with OPDIVO after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

OPDIVO

Tumors disappeared completely
(complete response)

 5 out of 53 people, or 9%, saw tumors disappear completely in response to OPDIVO® for colorectal cancer.

Tumors shrank
(partial response)

12 out of 53 people, or 23%, saw tumors shrink in response to OPDIVO® for colorectal cancer.

Tumors shrank or disappeared completely (overall response)

17 out of 53 people, or 32%, saw tumors shrink or disappear completely in response to OPDIVO® for colorectal cancer.

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 whose MSI-H/dMMR CRC has spread to other parts of the body (metastatic) and who have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working

OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

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-2400031   03/24