The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Shire's Onivyde (irinotecan pegylated liposomal formulation) for approval.
The drug is intended for the 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.
It was originally developed by Baxalta, which was taken over by Shire earlier this year.
"There has been little improvement in the prognosis for patients with metastatic pancreatic cancer in over 20 years," said Philip Vickers, head of R&D, of Shire. "We therefore welcome the CHMP positive opinion for Onivyde, a regulatory milestone which brings us a step closer to helping patients with this devastating disease."
Pancreatic cancer is the third leading cause of cancer death in the region. In September 2015, 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. Gemcitabine-based therapy is commonly used as a first-line treatment for patients with metastatic disease or locally advanced disease who cannot be treated with surgery, or as adjuvant therapy.