Ipilimumab (5) – Yervoy®
Renal cell carcinoma (RCC), first-line, combination with nivolumab
Characteristics
| Start date | 15.02.2019 – Marketing authorisation: 11.01.2019 |
|---|---|
| Resolution | 15.08.2019 |
| INN | Ipilimumab |
| Brand name | Yervoy® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-440 |
| ATC code | L01FX04 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| ICD-10 codes (AIS) | C64Malignant neoplasm of kidney, except renal pelvis |
| Alpha-ID codes (AIS) | I19876Renal cell carcinoma |
| DDD | 10 mg P |
| Therapeutic area | Oncological diseases Renal cell carcinoma (RCC) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with non-pretreated advanced renal cell carcinoma with intermediate risk profile (IMDC score 1-2). | - Bevacizumab in combination with interferon alfa-2a or - monotherapy with pazopanib or - Monotherapy with sunitinib |
| b) | Adult patients with non-pretreated advanced renal cell carcinoma with unfavourable risk profile (IMDC score ≥ 3). | - Sunitinib oder - Temsirolimus |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CheckMate 214) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
- Clinical trials
- For the benefit assessment of the active ingredient ipilimumab, the pharmaceutical manufacturer submitted the randomised, open-label, multicentre Phase III trial CheckMate 214 (CA209-214).
Courtesy translation only, please refer to the German original.
Associated procedures
| Ipilimumab (6) | Yervoy® | Bristol-Myers Squibb Pharma EEIG | Non-small cell lung carcinoma (NSCLC), first line, combination with nivolumab and platin-based chemotherapy | 14,340–16,180 | 73% Indication of minor additional benefit | |
| Ipilimumab (5) | Yervoy® | Bristol-Myers Squibb GmbH & Co. KGaA | Renal cell carcinoma (RCC), first-line, combination with nivolumab | 2,110–2,850 | 100% Indication of considerable additional benefit | |
| Ipilimumab (4) | Yervoy® | Bristol-Myers Squibb GmbH & Co. KGaA | Melanoma, combination with nivolumab | 2,500–4,500 | 85% additional benefit not proven | |
| Ipilimumab (3) | Yervoy® | Bristol-Myers Squibb GmbH & Co. KGaA | Melanoma, ≥ 12 to < 18 years | 1–5 | 100% additional benefit not proven | |
| Ipilimumab (2) | Yervoy® | Bristol-Myers Squibb GmbH & Co. KGaA | Melanoma, first-line | 500–1,500 | 100% additional benefit not proven | |
| Ipilimumab (1) | Yervoy® | Bristol-Myers Squibb GmbH & Co. KGaA | Melanoma, second-line | 3,100 | 100% Indication of considerable additional benefit |
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