Drug Approval | April 12, 2025
FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers
The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab
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