ONIVYDE® obtains TFDA Approval for the new regimen in First-line Treatment of Metastatic PDAC.
Filed post-approval change application for a new indication of ONIVYDE ® 1L combination therapy (NALIRIFOX) for mPDAC to TFDA.
Europe EMA accepted Type II Variation application for ONIVYDE®, PharmaEngine received US$2 million of sublicense revenue.
Published first results for ONIVYDE® in combination with LONSURF® in refractory solid tumors at ASCO-GI 2022.
China NMPA approved ONIVYDE® regimen as the 2L treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
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).
Japan MHLW approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
US FDA granted Fast Track designation for ONIVYDE® as a 1L combination therapy (NALIRIFOX) treatment for mPDAC.
Singapore HSA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
Taiwan Health Insurance Administration added ONIVYDE ® to the health insurance benefits, effective on Aug. 1, 2018.
South Korea MFDS approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
Taiwan FDA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
EU EMA approved ONIVYDE® as the 2L regimen for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
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®.
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 more than 40 countries, including Taiwan, US, EU, Singapore, South Korea, Japan, China, and many countries. In first-quarter 2024, ONIVYDE® regimen (NALIRIFOX) for 1L PDAC has obtained approvals in the US, Australia, and Taiwan.
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.
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