Post Marketing Surveillance Study for ONIVYDE® in South Korea

Post Marketing Surveillance Study for ONIVYDE® in South Korea

The purpose of this study is to characterize the safety of ONIVYDE when used under standard clinical practice in South Korea; and to describe effectiveness in patients receiving ONIVYDE in combination with 5-fluorouracil (5-FU) and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in South Korea.

Inclusion Criteria:

Patients who are prescribed ONIVYDE per investigator's judgment shall be included if:

• Patient / legally authorized representative/ family member gave written informed consent
• Patient is indicated for treatment according to ONIVYDE South Korea prescribing information
• Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
• Documented metastatic disease
• Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy
• Adequate hepatic, renal and hematological function

Exclusion Criteria:

• Patients enrolled in Servier sponsored ONIVYDE Registry or any other Servier sponsored ONIVYDE study
• Patients who have experienced severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL
• Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation of interstitial lung disease. Patients with confirmed diagnosis of interstitial lung disease