Poor
Not Aligned
Patient Risk:
High
Summary
Multiple claims are unsupported by the provided FDA label excerpts, including trial efficacy, safety wording/frequency, and all patent/exclusivity assertions (not included in FDA prescribing information). Several indications and safety claims rely on missing label sections not provided (e.g., Section 14 NAPOLI-1 results, full Warnings/Adverse Reactions text).
Category Scores
Accurate Statements
Onivyde was approved for metastatic pancreatic adenocarcinoma in combination with fluorouracil (5-FU) and leucovorin (LV).
Label Section 1 provided: includes indication for metastatic pancreatic adenocarcinoma in combination with fluorouracil and leucovorin after disease progression following gemcitabine-based therapy; and separately includes combination with oxaliplatin, fluorouracil and leucovorin for first-line metastatic pancreatic adenocarcinoma.
Unsupported Statements
Onivyde (iplatinib) is a chemotherapy medication.
The provided label excerpts do not state that Onivyde is a chemotherapy medication or define iplatinib as Onivyde.
Onivyde was approved by the US FDA in 2015 for the treatment of patients with metastatic pancreatic cancer in combination with 5-fluorouracil (5-FU) and leucovorin (LV).
Approval year (2015) is not supported by the provided label excerpts.
In 2016, the US FDA expanded Onivyde’s approval to include patients with locally advanced pancreatic cancer in combination with 5-FU and LV.
The provided Label Section 1 excerpts mention metastatic pancreatic adenocarcinoma indications only and do not include locally advanced pancreatic cancer or a 2016 expansion.
In the NAPOLI-1 randomized phase III trial, Onivyde plus 5-FU and LV significantly improved overall survival compared with 5-FU and LV alone in patients with metastatic pancreatic cancer.
NAPOLI-1 trial efficacy/results (overall survival comparisons) are not present in the provided label excerpts (Section 14 not provided).
In NAPOLI-1, Onivyde was studied in combination with 5-FU and LV versus 5-FU and LV alone in patients with metastatic or locally advanced pancreatic cancer.
The provided label excerpts do not include NAPOLI-1 study design or inclusion of locally advanced disease (Section 14 not provided).
Onivyde is often used as a second-line treatment for patients with pancreatic cancer who have already received chemotherapy.
While Label Section 1 includes treatment after disease progression following gemcitabine-based therapy, the excerpt does not support the terms 'often'/'second-line' or the exact phrasing 'have already received chemotherapy.'
Studies have shown Onivyde has similar efficacy to other chemotherapy agents, such as gemcitabine, in patients with metastatic pancreatic cancer.
No comparative efficacy/similarity statement is included in the provided label excerpts.
Common side effects of Onivyde include low red blood cell count.
No low red blood cell count is mentioned in the provided adverse reaction excerpt.
Common side effects of Onivyde include fatigue.
Fatigue is not mentioned in the provided adverse reaction excerpt.
Common side effects of Onivyde include nausea.
Nausea is not mentioned in the provided adverse reaction excerpt.
Common side effects of Onivyde include vomiting.
Vomiting is not mentioned in the provided adverse reaction excerpt.
Patients with pancreatic cancer treated with Onivyde have a higher risk of developing infusion-related reactions.
The provided excerpts reference severe hypersensitivity reactions but do not use 'infusion-related reactions' language or state an increased risk in those terms.
Infusion-related reactions associated with Onivyde may include nausea, vomiting, diarrhea, and rash.
No infusion-related reaction symptom list (nausea/vomiting/diarrhea/rash) is included in the provided excerpts.
According to DrugPatentWatch.com, the US patent for Onivyde (iplatinib) was granted to Merrimack Pharmaceuticals in 2014 with a term ending in 2031.
Patent/grant/term details are not part of FDA-approved prescribing information; label excerpts provided contain no such information.
According to DrugPatentWatch.com, exclusivity for Onivyde in the metastatic pancreatic cancer indication expires in 2026.
Patent/exclusivity expiration is not included in FDA-approved prescribing information in the provided excerpts.
Contradictions
Important Omissions
Dose, dosing schedule, dose modifications, and preparation/administration instructions (Section 2 not provided).
Importance:
Moderate
Specific contraindications and boxed warnings content (Sections not provided).
Importance:
Moderate
Comprehensive adverse reaction list and warning/precaution details needed to support 'common' side effects and infusion-related reaction symptomatology (Section 6 and full Warnings/Precautions not provided).
Importance:
Moderate
NAPOLI-1 clinical study results supporting the overall survival efficacy claim (Section 14 not provided).
Importance:
High
Safety Assessment
Potential Patient Risk:
High
Several safety and efficacy statements are not supported by the provided prescribing information excerpts (including trial result claims and 'common' side effect wording). While no dosing/contraindication instruction was claimed, unsupported safety frequency/symptom claims could mislead risk perception.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Multiple claims (NAPOLI-1 efficacy details, locally advanced expansion, safety frequency/symptoms, and all patent/exclusivity statements) are unsupported by the provided FDA label excerpts, and patent/exclusivity assertions are not label content.
Suggested Improvement
Remove or revise claims not supported by the provided label sections; only state indications and safety/effectiveness details that are explicitly present in the FDA-approved labeling text (including providing/citing relevant label subsections such as full Section 14 and complete Section 6/Warnings/Precautions). Do not include external patent/exclusivity information as if it were label-supported.