Product Overview

ONIVYDE®

is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In ONIVYDE®, irinotecan is enclosed in tiny fat particles called 'liposomes', which accumulate in the tumor and release slowly over time.

ONIVYDE® in combination with fluorouracil and leucovorin  is currently launched in most major markets including the U.S., Europe and Asia for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression.
 

Milestones

2024

March

ONIVYDE® obtains TFDA Approval for the new regimen in First-line Treatment of Metastatic PDAC.

2023

June

Filed post-approval change application for a new indication of ONIVYDE ® 1L combination therapy (NALIRIFOX) for mPDAC to TFDA.

 

July

Europe EMA accepted Type II Variation application for ONIVYDE®, PharmaEngine received US$2 million of sublicense revenue.

2022

January

Published first results for ONIVYDE® in combination with LONSURF® in refractory solid tumors at ASCO-GI 2022.

 

April

China NMPA approved ONIVYDE® regimen as the 2L treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

 

November

Positive topline results from Phase III NAPOLI-3 trial of ONIVYDE® regimen (NALIRIFOX) as a first-line treatment for previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

2020

March

Japan MHLW approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

 

June

US FDA granted Fast Track designation for ONIVYDE® as a 1L combination therapy (NALIRIFOX) treatment for mPDAC.

2018

January

Singapore HSA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

 

July

Taiwan Health Insurance Administration added ONIVYDE ® to the health insurance benefits, effective on Aug. 1, 2018.

2017

September

South Korea MFDS approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

 

2016

March

Taiwan FDA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

 

October

EU EMA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

2015

October

US FDA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy and Taiwan FDA accepted new drug application of ONIVYDE®.

Market Scope

ONIVYDE® is currently used for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. ONIVYDE® has received marketing approvals in the US, Europe, Asia and many more countries around the world. In 2024, ONIVYDE® regimen (NALIRIFOX) for 1L PDAC has obtained approvals in the US, Australia, Taiwan, and the EU.

According to the latest estimates by the World Health Organization, the global number of new cases of pancreatic cancer in 2025 is estimated to be 548,963, in particular, 64,265 in the US, 150,273 in Europe, 127,748 in China, and 50,350 in Japan.

According to Taiwan's Cancer Registry Annual Report from Health Promotion Administration, in 2021, there were 3,190 patients with initial diagnosis of pancreatic cancer and 2,659 patients' cause of death was pancreatic cancer in Taiwan.

Clinical Development

 

References

NALIRIFOX VERSUS NAB-PACLITAXEL AND GEMCITABINE IN TREATMENT-NAÏVE PATIENTS WITH METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (NAPOLI 3): A RANDOMISED, OPEN-LABEL, PHASE 3 TRIAL, Lancet. 2023; 10409: 1272-1281

Zev A Wainberg, MD, Davide Melisi, MD, Teresa Marcarulla, MD, Roberto Pazo Cid, MD, Sreenivasa R Chandana, MD, Christelle De Le Fouchardiere, MD et al. 

NANOLIPOSOMAL IRINOTECAN WITH FLUOROURACIL AND FOLINIC ACID IN METASTATIC PANCREATIC CANCER AFTER PREVIOUS GEMCITABINE-BASED THERAPY (NAPOLI-1): A GLOBAL, RANDOMISED, OPEN-LABEL, PHASE 3 TRIAL, Lancet. 2016; 387: 545-57

Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group

A MULTINATIONAL PHASE II STUDY OF LIPOSOME IRINOTECAN (PEP02) FOR PATIENTS WITH GEMCITABINE-REFRACTORY METASTATIC PANCREATIC CANCER, British Journal of Cancer 2013; 109: 920–25

A. H. Ko, M. A. Tempero, Y. Shan, W. Su, Y. Lin, E. Dito, A. Ong, G. Yeh, L. Chen

MANAGEMENT OF METASTATIC PANCREATIC CANCER: CURRENT TREATMENT OPTIONS AND POTENTIAL NEW THERAPEUTIC TARGETS, Critical Reviews in Oncology/Hematology, 2015; 95: 318-36

Sclafani F, Iyer R, Cunningham D, Starling N

A RANDOMIZED PHASE II STUDY OF PEP02 (MM-398), IRINOTECAN OR DOCETAXEL AS A SECOND-LINE THERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC OR GASTRO-OESOPHAGEAL JUNCTION ADENOCARCINOMA, Ann Oncol. 2013; 24: 1567–73

Roy AC, Park SR, Cunningham D, Kang YK, Chao Y, Chen LT, Rees C, Lim HY, Tabernero J, Ramos FJ, Kujundzic M, Cardic MB, Yeh CG, de Gramont A

PHASE I STUDY OF NANOLIPOSOMAL IRINOTECAN (PEP02) IN ADVANCED SOLID TUMOR PATIENTS, Cancer Chemother Pharmacol 2015; 75: 579–86

Chang TC, Shiah HS, Yang CH, Yeh KH, Cheng AL, Shen BN, Wang YW, Yeh CG, Chiang NJ, Chang JY, Chen LT

CONVECTION-ENHANCED DELIVERY OF NANOLIPOSOMAL CPT-11 (IRINOTECAN) AND PEGYLATED LIPOSOMAL DOXORUBICIN (DOXIL) IN RODENT INTRACRANIAL BRAIN TUMOR XENOGRAFTS, Neuro Oncol. 2007; 9: 393-403

Krauze MT, Noble CO, Kawaguchi T, Drummond D, Kirpotin DB, Yamashita Y, Kullberg E, Forsayeth J, Park JW, Bankiewicz KS

PEP07

More