It is proposed that Onivyde be prescribed by physicians experienced in the use of therapies. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official EU languages after the marketing authorisation has been granted by the European Commission. Overall international regulatory status The overall international regulatory status at time of the current submission to TGA is shown in Table 2. Table 2: International regulatory status. Country / Submission Approval Status Indications (approved or region date date requested) US 24 Apr 2015 22 Oct Approved Onivyde is a topoisomerase 2015 inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. EU 30 Apr 2015 CHMP Treatment of metastatic – centralised positive adenocarcinoma of the procedure opinion pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy. Switzerland 5 Nov 2015 Treatment of metastatic review adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in patients who have been previously treated with gemcitabine. Canada 18 Dec 2015 Under Treatment of metastatic review adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in patients who have been previously treated with gemcitabine-based therapy. New Zealand 25 Mar 2016 Under Treatment of metastatic review adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in patients who have been previously treated with gemcitabine.
It is proposed that Onivyde be prescribed by physicians experienced in the use of therapies. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official EU languages after the marketing authorisation has been granted by the European Commission. Overall international regulatory status The overall international regulatory status at time of the current submission to TGA is shown in Table 2. Table 2: International regulatory status. Country / region Submission date Approval date Status Indications (approved or requested) US 24 Apr 2015 22 Oct 2015 Approved Onivyde is a topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. EU – centralised procedure 30 Apr 2015 CHMP positive opinion Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy. Switzerland 5 Nov 2015 review Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in patients who have been previously treated with gemcitabine. Canada 18 Dec 2015 Under review Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in patients who have been previously treated with gemcitabine-based therapy. New Zealand 25 Mar 2016 Under review Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin in patients who have been previously treated with gemcitabine.
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