Nivolumab (28) – Opdivo®
Urothelial carcinoma, first-line, combination with cisplatin and gemcitabine
Characteristics
| Start date | 01.07.2024 – Marketing authorisation: 23.05.2024 |
|---|---|
| Resolution | 19.12.2024 |
| INN | Nivolumab |
| Brand name | Opdivo® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-1081 |
| ATC code | L01FF01 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C65Malignant neoplasm of renal pelvis, C66Malignant neoplasm of ureter, C67.0Malignant neoplasm of trigone of bladder, C67.1Malignant neoplasm of dome of bladder, C67.2Malignant neoplasm of lateral wall of bladder, C67.3Malignant neoplasm of anterior wall of bladder, C67.4Malignant neoplasm of posterior wall of bladder, C67.5Malignant neoplasm of internal urethral orifice, C67.6Malignant neoplasm of ureteric orifice, C67.7Malignant neoplasm of urachus, C67.8Malignant neoplasm of overlapping sites of bladder, C67.9Malignant neoplasm of bladder, unspecified, C68.0Malignant neoplasm of urethra, C68.8Primary malignant neoplasm of two or more contiguous sites of urinary organs whose point of origin cannot be determined, C68.9Malignant neoplasm of urinary system NOS |
| Alpha-ID codes (AIS) | I104386Malignant neoplasm of the urinary bladder sphincter, I13895Malignant neoplasm of the urinary bladder, I14845Malignant neoplasm of the neck of the bladder, I15288Malignant neoplasm of the posterior bladder wall, I15360Malignant neoplasm of the lateral bladder wall, I15411Malignant neoplasm of the anterior bladder wall, I20177Malignant neoplasm of the renal pelvis, I20685Malignant neoplasm of the ostium ureteris, I22423Malignant neoplasm of the trigonum vesicae, I22501Malignant neoplasm of the urachus, I22610Malignant neoplasm of the ureter, I22762Malignant neoplasm of the urethra, I22909Urothelial carcinoma, I30262Malignant neoplasm of the apex vesicae |
| Therapeutic area | Oncological diseases Urothelial carcinoma (UC) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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OPDIVO is indicated in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with unresectable or metastatic urothelial carcinoma; first-line treatment | Cisplatin in combination with gemcitabine followed by avelumab as maintenance therapy (maintenance therapy with avelumab only for patients who are progression-free) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CheckMate 901) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
- Clinical trials
- The pharmaceutical manufacturer has submitted the results of the randomised, open-label Phase III trial CA209-901 (CheckMate 901) to demonstrate the additional benefit.
- Of the four-arm trial, only the two treatment arms in which nivolumab + cisplatin + gemcitabine was compared with cisplatin + gemcitabine were relevant to this benefit assessment.
Adults with unresectable or metastatic urothelial carcinoma; first-line treatment
- The additional benefit is not proven.
- Consequently, the G-BA concludes that an additional benefit is not proven for nivolumab in combination with cisplatin and gemcitabine in the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
- In the CheckMate 901 trial, approximately 50 per cent of patients in the control arm receiving cisplatin + gemcitabine were not adequately treated with avelumab, despite being eligible for maintenance therapy with avelumab; consequently, the appropriate comparator therapy was not implemented for a significant proportion of patients.
- Consequently, no evaluable data are available for the benefit assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
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