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The FDA has approved Opdivo with Yervoy for patients 12 years old and older with MSI-H or dMMR colorectal cancer.
The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) with Yervoy (ipilimumab) for adult and pediatric patients 12 years old and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), the agency has announced.
The agency has also converted its accelerated approval to a regular approval for single-agent Opdivo for adult and pediatric patients 12 years old and older with MSI-H or dMMR metastatic CRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.
Glossary
Progression-free survival: the time a patient lives without their disease spreading or worsening.
Objective response rate: the patients who responded partially or completely to treatment.
Overall survival: the time a patient lives, regardless of disease status.
Pruritis: itching.
The effectiveness of the Opdivo and Yervoy regimen was shown in the phase 3 CHEKCMATE-8HW trial among immunotherapy-naive patients with unresectable or metastatic CRC with known MSI-H or dMMR status, with patients randomized to receive 240 milligrams of Opdivo every three weeks and 1 milligram per kilogram of Yervoy every three weeks for a maximum of four doses then 480 milligrams of Opdivo every four weeks, 240 milligrams of Opdivo every two weeks for six doses and then 480 milligrams of Opdivo every four weeks or investigator’s choice chemotherapy.
Regarding Opdivo and Yervoy versus chemotherapy, median progression-free survival was not reached in the Opdivo plus Yervoy arm and 5.8 months in the chemotherapy arm, according to the agency, which noted that comparative results of objective response rate and overall survival between arms were not available at the time of the interim progression-free survival analysis.
Regarding Opdivo and Yervoy versus standalone Opdivo, median progression-free survival was not reached in the combination arm and 39.3 months in the Opdivo arm. The objective response rate was 71% in the combination arm and 58% in the monotherapy arm. Comparative results of overall survival between arms were not available at the time of the interim progression-free survival analysis.
The most common side effects, reported in at least 20% of patients treated with Opdivo plus Yervoy, were fatigue, diarrhea, pruritus, abdominal pain, musculoskeletal pain and nausea, the agency reported, and the most common side effects reported in at least20% of patients treated with single-agent Opdivo were fatigue, diarrhea, abdominal pain, pruritis and musculoskeletal pain.
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