Drugs / Irinotecan liposome injection
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Onivyde | pancreatic ductal adenocarcinoma | 2023-06-14 | “the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) Onivyde®” ipsen.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05383352 | May 2022 → May 2024 | pancreatic adenocarcinoma | Ipsen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-05-31 | Ipsen | Results Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma ipsen.com ↗
Post-hoc analysis of NAPOLI 3 study determined characteristics associated with long-term survival, with median overall survival of 19.5 months amongst long-term survivors receiving Onivyde® plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy2 |
| 2024-02-13 | Ipsen | Regulatory Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). |
| 2023-06-14 | Ipsen | Regulatory Correction: Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma ipsen.com ↗ |
| 2023-01-20 | Ipsen | Results Ipsen presents Phase III NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI ipsen.com ↗
Investigational Onivyde® (irinotecan liposome injection) in the NALIRIFOX treatment regimen demonstrated statistically significant improvements in overall survival and progression-free survival compared to nab-paclitaxel plus gemcitabine with a manageable safety profile1 |
| 2022-11-09 | Ipsen | Results Onivyde® regimen demonstrated statistically significant improvement in overall survival in previously untreated metastatic pancreatic ductal adenocarcinoma ipsen.com ↗
Trial met its primary endpoint with Onivyde® (irinotecan liposome injection) in the NALIRIFOX treatment regimen showing statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen |
| 2022-08-03 | Ipsen | Results Ipsen announces results from Phase III RESILIENT trial evaluating Onivyde® in second-line monotherapy for small cell lung cancer ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. |
| 2020-11-30 | Ipsen | Regulatory Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE®) as a second-line monotherapy treatment for small cell lung cancer (SCLC) ipsen.com ↗ |
| 2020-07-01 | Ipsen | Results Ipsen presents Phase I/II clinical data evaluating liposomal irinotecan (Onivyde®) as an investigational first-line combination treatment for metastatic pancreatic cancer at the ESMO World Congress on Gastrointestinal Cancer ipsen.com ↗
The results include safety and efficacy analyses from the multicenter, open-label, study consisting of dose-exploration safety run-in (traditional 3+3 design) to confirm the maximum tolerated dose and appropriate dose regimen for NALIRIFOX in the dose-expansion phase. |
| 2019-07-05 | Ipsen | Results Ipsen and Servier announce initial Phase 1/2 clinical data evaluating liposomal irinotecan (ONIVYDE®) as an investigational first-line treatment for metastatic pancreatic cancer at ESMO 21st World Congress on Gastrointestinal Cancer ipsen.com ↗ |
| 2019-05-24 | Ipsen | Results New investigational clinical data for Ipsen’s oncology products in 11 solid tumor types to be presented at 2019 ASCO Annual Meeting ipsen.com ↗
Preliminary results from the RESILIENT study of liposomal irinotecan injection in patients with small cell lung cancer |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Irinotecan liposome injection | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05383352 ↗ |
| Route | Intravenous | “intravenously over 90 minutes” NCT05383352 ↗ |