Approvals

This approval is the second for an Onivyde regimen in mPDAC, following one in 2015 for Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

Christelle Huguet, EVP and head of research and development at Ipsen, commented: “The results from the phase 3 NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen. With today’s approval, this Onivyde (Nalirifox) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the US.”

Dr Zev Wainberg, professor of medicine and co-director of the UCLA GI Oncology Programme, added: “Metastatic pancreatic adenocarcinoma is a difficult disease to manage with very few available treatment options. Given the reality of this aggressive form of cancer and the complexity of the disease, every advance in the treatment landscape represents a meaningful improvement in patient outcomes. The approval of this Onivyde regimen is an important milestone for people living with mPDAC, their families and healthcare providers, with the NAPOLI 3 trial having demonstrated survival benefits versus a current standard-of-care treatment option.”

Julie Fleshman JD MBA, president and CEO of Pancreatic Cancer Action Network (PanCAN), stated: “We are pleased that the FDA has issued this new approval of the Nalirifox regimen. With each new approved treatment, there is more hope for those who will be diagnosed in the future and people currently living with pancreatic cancer may have more time with their loved ones. We are thankful to the patients who participated in this clinical trial as they play a crucial role in advancing treatments for pancreatic cancer.”