FDA Approves Onivyde for First-line Metastatic Pancreatic Cancer

The FDA has approved Ipsen’s supplemental new drug application for Onivyde (irinotecan liposome) as a first-line treatment for adults with metastatic pancreatic adenocarcinoma. It is indicated to be used with the chemotherapy regimen oxaliplatin, fluorouracil and leucovorin (NALIRIFOX)

Pancreatic adenocarcinoma is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the United States each year. It is often detected after the disease has spread and has a poor prognosis with fewer than 20% of people surviving longer than one year.

“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,” Zev Wainberg, M.D., professor of Medicine and co-director of the UCLA GI Oncology Program, said in a press release.

Onivyde blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. It is administered via intravenous infusion over 90 minutes every two weeks. It is already approved in combination with fluorouracil and leucovorin to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

The current FDA approval was based on efficacy and safety data from NAPOLI 3, a phase 3 pivotal trial that enrolled 770 patients with metastatic pancreatic adenocarcinoma without prior treatment.

The study demonstrated that Onivyde plus the NALIRIFOX regimen provided a statistically significant improvement in median overall survival of 11.1 months compared with 9.2. months for patients treated with nab-paclitaxel and gemcitabine. At 12 months, the overall rate for the Onivyde plus NALIRIFOX group was 45.6%, and for the nab-paclitaxel and gemcitabine group it was 39.5%. At 18 months, the overall survival rate was 26.2% for the NALIRIFOX group, and 19.3% for the nab-paclitaxel and gemcitabine group.

The trial also met its secondary endpoint, showing that patients treated with Onivyde plus NALIRIFOX had a statistically significant improvement in median progression-free survival of 7.4 months versus 5.6 months for nab-paclitaxel and gemcitabine.

The most common grade 3/4 treatment-emergent adverse events were diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation and decreased weight.