Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-small cell lung carcinoma in adult patients whose tumors have no EGFR or ALK positive mutations. This indication is based on results from KEYNOTE-024, where patients received pembrolizumab in combination with investigator's choice of platinum-containing chemotherapy, including: pemetrexed with carboplatin, pemetrexed with cisplatin, gemcitabine and cisplatin, gemcitabine and carboplatin, or paclitaxel and carboplatin.
This is written in the approval document as:
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.
Citation
Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Pembrolizumab, Pemetrexed | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Pembrolizumab, Pemetrexed | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Gemcitabine, Pembrolizumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Gemcitabine, Pembrolizumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Paclitaxel, Pembrolizumab |