Pembrolizumab (8) (Keytruda®) – Melanoma, adjuvant therapy

Characteristics

Start date 01.04.2019
Resolution 19.09.2019
Limitation date 01.04.2024 limitation repealed
INN Pembrolizumab
Brand name Keytruda®
Pharm. company MSD Sharp & Dohme GmbH
G-BA procedure ID 2019-04-01-D-446
ATC code L01FF02
DDD 9.5 mg P
Therapeutic area Oncological diseases
Reason for procedure New Indication
Specialty Bundling Special practice conditions

Indication (German)

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

Subpopulation Indication Comparator
A) Monotherapy indicated for adjuvant treatment of melanoma in tumour stage III with lymph node involvement after complete resection in adults Observational waiting

9. Associated procedures

Resolution INN Brand name Indication Patients Additional benefit
Pembrolizumab Keytruda® Melanoma 2,500 – 4,500
Pembrolizumab (2) Keytruda® Non-small cell lung carcinoma (NSCLC), after prior chemotherapy 12,500 – 24,300
Pembrolizumab (3) Keytruda® Non-small cell lung carcinoma (NSCLC), first-line 4,000
Pembrolizumab (4) Keytruda® Hodgkin lymphoma (HL) 60 – 180
Pembrolizumab (5) Keytruda® Urothelial carcinoma (UC) 1,500 – 1,900
2,300 – 3,300
Pembrolizumab (6) Keytruda® Squamous cell carcinoma head and neck 470 – 3,290
Pembrolizumab (7, reassessment) Keytruda® Urothelial carcinoma (UC), CPS ≥ 10, first-line 0
240 – 420
Pembrolizumab (8) Keytruda® Melanoma, adjuvant therapy 2,670 – 3,400
Pembrolizumab (9) Keytruda® Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, first-line, combination with pemetrexed and platinum chemotherapy 8,020 – 9,120
Pembrolizumab (10) Keytruda® Non-small cell lung carcinoma (NSCLC), squamous cell histology, first-line, combination with carboplatin and (nab-) paclitaxel 5,340 – 5,570
Pembrolizumab (11) Keytruda® Renal cell carcinoma (RCC), first-line, combination with axitinib 3,500
Pembrolizumab (12) Keytruda® Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, monotherapy 4,955 – 5,370
Pembrolizumab (13) Keytruda® Squamous cell carcinoma head and neck, PD-L1 expression ≥ 1%, first-line, combination with platinum and 5-fluorouracil (5-FU) chemotherapy 4,950 – 5,370
Pembrolizumab (14) Keytruda® Colorectal carcinoma (CRC) with MSI-H or dMMR, first-line 370 – 955
Pembrolizumab (15, reassessment) Keytruda® Urothelial carcinoma (UC), CPS ≥ 10, first-line 225 – 380
Pembrolizumab (16) Keytruda® Hodgkin lymphoma (HL), pre-treated patients, ≥ 3 years 120 – 240
Pembrolizumab (17) Keytruda® Mammary carcinoma (BC), triple-negative, PD-L1 expression ≥ 10 (CPS), combination with chemotherapy 260 – 270
Pembrolizumab (18) Keytruda® Carcinoma of the esophagus or gastroesophageal junction, PD-L1 expression ≥ 10 (CPS), first-line, combination with platinum- and fluoropyrimidine-based chemotherapy. 535 – 805
Pembrolizumab (19) Keytruda® Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib n.d.
Pembrolizumab (20) Keytruda® Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib n.d.
Pembrolizumab (21) Keytruda® Breast carcinoma (BC), triple-negative (TNBC), high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or combination with chemotherapy n.d.


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