ONIVYDE (pegylated liposomal irinotecan), antineoplastic agent

ONCOLOGY - New medicinal product

Opinions on drugs - Posted on Oct 04 2017

Inclusion

ONIVYDE has marketing authorisation in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in the treatment of metastatic pancreatic adenocarcinoma in adult patients after disease progression following treatment with gemcitabine.
With the addition to 5-FU/LV, it has demonstrated a modest gain in terms of overall survival (median +1.9 months) compared with 5-FU/LV alone, but at the cost of a lower tolerance.
Due to the inappropriate choice of the comparator and the dose differences in the 5-FU/LV administration regimens between the two groups (to the detriment of the control group), the scope and transferability of these results is limited.

Substantial

no clinical added value

Therapeutic use

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