Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that dMMR status confers therapeutic sensitivity to Ipilimumab, Nivolumab in patients with Colorectal Adenocarcinoma.
The European Medicines Agency (EMA) has authorized nivolumab in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
This statement is based on a regulatory approval from the European Medicines Agency:
OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
Citation
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-09-04 | Van Allen lab | On 2025-01-13, the EMA published an EPAR - Assessment report - Variation for Opdivo (nivolumab) for that added an extension indication to nivolumab in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. |
| 2024-12-19 | European Medicines Agency | Indication received approval from the European Commission. |