Active Ingredient: Durvalumab
Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient weight is > 30 kg :
Intravenous, 1,120 milligrams durvalumab, once every 3 weeks. This step is repeated 4 to 6 times. Afterwards, intravenous, 1,500 milligrams durvalumab, once every 4 weeks.
Regimen B, in the case that patient weight is ≤ 30 kg :
Intravenous, 1,120 milligrams durvalumab, once every 3 weeks. This step is repeated 4 to 6 times. Afterwards, intravenous, 20 milligrams durvalumab per kilogram of body weight, once every 3 weeks.
1,120 mg in combination with carboplatin and paclitaxel every 3 weeks (21 days) for a minimum of 4 and up to 6 cycles, followed by durvalumab 1,500 mg every 4 weeks as monotherapy (dMMR patients) or in combination with olaparib 300 mg twice daily (pMMR patients).
Endometrial cancer patients with a body weight of 30 kg or less during maintenance phase must receive weight-based dosing equivalent to durvalumab at 20 mg/kg, until weight is greater than 30 kg.
Until disease progression or unacceptable toxicity.
Dose escalation or reduction is not recommended. Treatment withholding or discontinuation may be required based on individual safety and tolerability.
It is to be administered as an intravenous infusion solution over 1 hour.
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