Nivolumab

Nivolumab

Oncology

Indication extension

Bladder cancer

OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

Opdivo

BMS

Intermural (MSZ)

Centralised (EMA)

Normal trajectory

No

2025

2026

Yes

Clinical trials

NCT03036098

Possibly no place in the treatment regimen

De overall survival van de nivolumab-combinatie versus de gemcitabine–cisplatin enkel was (hazard ratio for death, 0,78; 95% confidence interval [CI], 0.63 tot 0,96; P=0.02); de mediane survival was 21,7 maanden (95% CI, 18.6 to 26.4) vergeleken met 18,9 maanden (95% CI, 14.7 to 22.4). Verwachting is dat dit niet voldoet aan PASKWIL-criteria. De nieuwe 1e lijns behandeling wordt mogelijk enfortumab-vedotin.

NKR2021

In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom (1). Dit betekent dat er maximaal 1.213 patiënten in aanmerking zullen komen in de eerste lijn.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.