Active Ingredient: Durvalumab
Durvalumab in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant durvalumab monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In the case that patient weight is > 30 kg and from cycle 1 until cycle 12 :
Intravenous, 1,500 milligrams durvalumab, once every 4 weeks.
Recommended durvalumab dose:
1 500 mg* in combination with FLOT chemotherapy every 4 weeks for up to 2 cycles prior to surgery, followed by 1 500 mg*, with FLOT chemotherapy, every 4 weeks for up to 2 cycles and then as 1 500 mg monotherapy every 4 weeks for up to 10 cycles, for a total of up to 12 cycles after surgery.
* GC/GEJC 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 progression or recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery.
When durvalumab is administered in combination with chemotherapy, administer durvalumab prior to chemotherapy on the same day.
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