Pembrolizumab (15) (Keytruda®) – Urothelial carcinoma (UC), CPS ≥ 10, first-line

1. Characteristics

Start date 01.04.2021
Resolution 16.09.2021
INN Pembrolizumab
Brand name Keytruda®
Company MSD Sharp & Dohme GmbH
G-BA procedure ID 2021-04-01-D-661
ATC code L01XC18
ICD-10 codes C68.9Malignant neoplasm of urinary system NOS
DDD 9.5 mg P
Therapeutic area Oncological diseases
Reason for procedure Reassessment due to limitation
Original resolution: Pembrolizumab (7, reassessment) (20.06.2019)
Specialties Bundling

Indication (German)

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10

Subgroup Indication Comparator
Erwachsene mit lokal fortgeschrittenem oder metastasierendem Urothelkarzinom, die nicht für eine Cisplatin-basierte Therapie geeignet sind und deren Tumoren PD-L1 mit einem kombinierten positiven Score (CPS) ≥ 10 exprimieren; Erstlinie Carboplatin in Kombination mit Gemcitabin (vgl. Anlage VI zum Abschnitt K der Arzneimittel-Richtlinie)

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Pembrolizumab Keytruda® Melanoma
Pembrolizumab (2) Keytruda® Non-small cell lung carcinoma (NSCLC), after prior chemotherapy
Pembrolizumab (3) Keytruda® Non-small cell lung carcinoma (NSCLC), first-line
Pembrolizumab (4) Keytruda® Hodgkin lymphoma (HL)
Pembrolizumab (5) Keytruda® Urothelial carcinoma (UC)
Pembrolizumab (6) Keytruda® Squamous cell carcinoma head and neck
Pembrolizumab (7, reassessment) Keytruda® Urothelial carcinoma (UC), CPS ≥ 10, first-line
Pembrolizumab (8) Keytruda® Melanoma, adjuvant therapy
Pembrolizumab (9) Keytruda® Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy
Pembrolizumab (10) Keytruda® Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel
Pembrolizumab (11) Keytruda® Renal cell carcinoma (RCC), first-line, combination with axitinib
Pembrolizumab (12) Keytruda® Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy
Pembrolizumab (13) Keytruda® Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy
Pembrolizumab (14) Keytruda® Colorectal carcinoma (CRC) with MSI-H or dMMR, first-line
Pembrolizumab (15) Keytruda® Urothelial carcinoma (UC), CPS ≥ 10, first-line
Pembrolizumab (16) Keytruda® Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years


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