The European Medicines Agency has now issued a green light for Shire's pancreatic therapy Onivyde, following its US approval in July this year.
The drug is has been cleared to treat 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.
Approval came on the back of data from the pivotal, Phase III NAPOLI-1 study, which met its primary endpoint in showing that Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate) combined with 5-FU/LV significantly boosted overall survival compared to the latter alone, with median overall survival of 6.1 months vs 4.2 months, respectively.
Other benefits were also observed, with significant increases in progression-free survival and objective response rate in patients taking Onivyde/5-FU/LV versus those on 5-FU/LV.
On the safety side, the most common side effects - classed as grade 3 or higher - with greater than five percent difference between the two treatment arms were were neutropenia, fatigue, diarrhoea, and vomiting.
"As the only treatment for metastatic pancreatic cancer following gemcitabine-based therapy that may improve patient survival, Onivyde is the first innovation that offers the potential to improve outcomes for this challenging patient population," said Philip Vickers, global head of Research and Development at Shire.
Pancreatic cancer is the third leading cause of cancer death in Europe. In September last year, the European Society of Medical Oncology (ESMO) stated that use of Onivyde, when available in all countries, may be the best option for second-line treatment of these patients following gemcitabine-based therapy.
The drug was originally developed by Baxalta, which was taken over by Shire earlier this year.