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) |
| DDD | 10 mg P |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- 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 |
<< List of all resolutions