Active Ingredient: Durvalumab
Durvalumab in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by durvalumab as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient weight is > 30 kg
Intravenous, 1,500 milligrams durvalumab, once every 3 weeks. This step is repeated 4 times. Afterwards, intravenous, 1,500 milligrams durvalumab, once every 4 weeks. This step is repeated 1 to 8 times.
Regimen B, in case that patient weight is ≤ 30 kg
Intravenous, 20 milligrams durvalumab per kilogram of body weight, once every 3 weeks. This step is repeated 4 times. Afterwards, intravenous, 20 milligrams durvalumab per kilogram of body weight, once every 4 weeks. This step is repeated 1 to 8 times.
1,500 mg in combination with chemotherapy every 3 weeks for 4 cycles prior to surgery, followed by 1,500 mg every 4 weeks as monotherapy for up to 8 cycles after surgery.
MIBC patients with a body weight of 30 kg or less must receive weight-based dosing of durvalumab at 20 mg/kg.
Neoadjuvant phase: until disease progression that precludes definitive surgery or unacceptable toxicity.
Adjuvant phase: until recurrence, unacceptable toxicity, or a maximum of 8 cycles after surgery.
Dose escalation or reduction is not recommended. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
Durvalumab is for intravenous use. It is to be administered as an intravenous infusion solution over 1 hour.
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