Regulatory approval
Published by the European Medicines Agency. Approved
The European Medicines Agency (EMA) has authorized nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of adult patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors haev PD-L1 expression >= 1%. This indication is based on CA209816, a randomized, open-label, phase 3 study where the selection of platinum-based chemotherapy was investigator's choice of paclitaxel and carboplatin, pemetrexed and cisplatin, or gemcitabine and cisplatin.
This is written in the approval document as:
OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1%.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| EMA (1) | PD-L1 >= 1% | Non-Small Cell Lung Cancer | Carboplatin, Nivolumab, Paclitaxel | |
| EMA (1) | PD-L1 >= 1% | Non-Small Cell Lung Cancer | Carboplatin, Nivolumab, Pemetrexed | |
| EMA (1) | PD-L1 >= 1% | Non-Small Cell Lung Cancer | Cisplatin, Gemcitabine, Nivolumab |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-20 | Van Allen lab | Adding EMA approvals for use to database |
| 2023-06-26 | European Medicines Agency | Indication received approval from the European Commission. |