Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of adult patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 1.
This is written in the approval document as:
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS >= 1.
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 (+) | PD-L1 (CPS) >= 1 | Head and Neck Squamous Cell Carcinoma | Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Head and Neck Squamous Cell Carcinoma | Carboplatin, Fluorouracil, Pembrolizumab | |
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Head and Neck Squamous Cell Carcinoma | Cisplatin, Fluorouracil, Pembrolizumab |