The European Commission has approved Shire’s Onivyde for the treatment of adults with metastatic adenocarcinoma of the pancreas, making it the first licensed treatment for this patient group in the EU.
Authorised as a second-line combination therapy, Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate) will be administered with 5-fluorouracil (5-FU) and leucovorin (LV) in adult patients who have progressed following treatment with Lilly’s Gemzar (gemcitabine).
The EU licensing follows FDA approval of the drug, after Shire won US marketing authorisation in October last year.
Data from the phase III trial NAPOLI-1 showed that the triple-drug treatment significantly extended overall survival at an average of 6.1 months compared to 4.2 months for the 5-FU and LV-only group.
As such Onivyde marks a first for this indication of pancreatic cancer patients for whom there has been little improvement in prognosis over the last twenty years.
Dr Philip Vickers, global head of R&D at Shire, commented: “The approval of Onivyde marks a significant step forward in Shire’s focus to develop and commercialise treatments that represent the most promising science in oncology.”
Pancreatic cancer is the fourth leading cause of cancer death in Europe and seventh worldwide, with typically poor prognosis and an estimated 330,400 deaths each year.
The global pancreatic cancer market has seen rapid growth in recent years and is forecast to reach worldwide sales of $1.6bn by 2017, with the majority of sales attributed to Celgene’s Abraxane (paclitaxel) in combination with Gemzar.