European Commission (EC) has granted Marketing Authorization of ONIVYDE, also known as nal-IRI or MM-398, 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.
ONIVYDE is the first and only approved treatment option for this patient population, said Shire in its announcement on Wednesday.
With this approval, Shire is authorized to market ONIVYDE in the 28 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. ONIVYDE was previously approved in the U.S. by the Food and Drug Administration (FDA), in October 2015.
“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 J. Vickers, Ph.D., Global Head of Research and Development at Shire. “The approval of ONIVYDE marks a significant step forward in Shire’s focus to develop and commercialize treatments that represent the most promising science in oncology.”, he added.
Pancreatic cancer is the fourth leading cause of cancer death in the region and there are limited treatment options available.iv In September 2015, the European Society of Medical Oncology (ESMO) stated that use of MM-398 (ONIVYDE) when available in all countries, may be the best option for patients following gemcitabine-based therapy.v Gemcitabine-based therapy is commonly used as a first-line treatment for patients with metastatic disease or locally advanced disease that cannot be treated with surgery, or as adjuvant therapy.vi
“The burden of pancreatic cancer for patients, their families and healthcare providers is profound and the treatment options available, especially to those with metastatic disease, have not substantially evolved for decades,” said Alfredo Carrato, M.D., Professor of Medical Oncology at Alcala University and Director of the Medical Oncology Department at Ramon y Cajal University Hospital in Madrid, Spain. “With the approval of ONIVYDE, we have the first and only treatment approved for metastatic adenocarcinoma following gemcitabine-based therapy, and an option that may improve patient survival. This is an important advance for the field of oncology and the lives of those impacted by pancreatic cancer.”
The Marketing Authorization is based on the data from the pivotal, Phase 3 NAPOLI-1 study that demonstrated ONIVYDE combined with 5-FU/LV significantly improved overall survival (OS) (primary endpoint), as well as progression-free survival (PFS) and objective response rate (ORR) relative to the 5-FU/LV control arm (secondary endpoints). In the trial, the most common Grade 3 or higher adverse events with greater than five percent difference in patients receiving ONIVYDE and 5-FU/LV, versus 5-FU/LV alone, were neutropenia, fatigue, diarrhoea, and vomiting, said Shire.