Nivolumab (15) (Opdivo®) – Melanoma, adjuvant therapy

1. Characteristics

Start date 01.04.2021
Resolution 16.09.2021
INN Nivolumab
Brand name Opdivo®
Company Bristol-Myers Squibb GmbH & Co. KGaA
G-BA procedure ID 2021-04-01-D-668
ATC code L01XC17
ICD-10 codes C43.0Malignant melanoma of lip, C43.1Malignant melanoma of eyelid, including canthus, C43.2Malignant melanoma of ear and external auricular canal, C43.3Malignant melanoma of other and unspecified parts of face, C43.4Malignant melanoma of scalp and neck, C43.5Malignant melanoma of trunk, C43.6Malignant melanoma of upper limb, including shoulder, C43.7Malignant melanoma of lower limb, including hip, C43.8Malignant melanoma of overlapping sites of skin, C43.9Malignant melanoma of unspecified site of skin
DDD 17 mg P
Therapeutic area Oncological diseases
Reason for procedure Reassessment due to limitation
Original resolution: Nivolumab (11) (21.02.2019)
Specialties ACT change

Indication (German)

OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Subgroup Indication Comparator
Adjuvante Behandlung des Melanoms mit Lymphknotenbeteiligung oder Metastasierung nach vollständiger Resektion bei Erwachsenen − Pembrolizumab (nur für Patienten im Tumorstadium III nach vollständiger Resektion) oder − Dabrafenib in Kombination mit Trametinib (nur für Patienten mit BRAF-V600-Mutation-positivem Melanom im Tumorstadium III nach vollständiger Resektion) oder − Beobachtendes Abwarten

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Nivolumab Opdivo® Melanoma
Nivolumab (2) Opdivo® Non-small cell lung carcinoma (NSCLC), squamous cell histology, after previous chemotherapy
Nivolumab (3) Opdivo® Non-small cell lung carcinoma (NSCLC), non-squamous cell histology, after previous chemotherapy
Nivolumab (4) Opdivo® Renal cell carcinoma (RCC)
Nivolumab (5) Opdivo® Melanoma, combination with ipilimumab
Nivolumab (6) Opdivo® Hodgkin lymphoma (HL)
Nivolumab (7) Opdivo® Squamous cell carcinoma head and neck
Nivolumab (8, reassessment) Opdivo® Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
Nivolumab (9) Opdivo® Urothelial carcinoma (UC)
Nivolumab (10, reassessment) Opdivo® Melanoma, BRAF V600 wild-type, first-line, combination with ipilimumab
Nivolumab (11) Opdivo® Melanoma, adjuvant therapy
Nivolumab (12) Opdivo® Renal cell carcinoma (RCC), first-line, combination with ipilimumab
Nivolumab (13) Opdivo® Non-small cell lung carcinoma (NSCLC), combination with ipilimumab and platinum-based chemotherapy, first-line
Nivolumab (14) Opdivo® Squamous cell carcinoma of esophagus, pretreated patients
Nivolumab (15) Opdivo® Melanoma, adjuvant therapy
Nivolumab (16) Opdivo® Renal cell carcinoma (RCC), first-line, combination with cabozantinib


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