Onivyde demonstrated efficacy in patients with previously treated metastatic pancreatic cancer. In a clinical trial, the drug showed a statistically significant improvement in overall survival compared to a placebo [1].
How is Onivyde's effectiveness measured?
Onivyde's effectiveness is primarily measured by overall survival (OS) and progression-free survival (PFS). Overall survival is the length of time patients live after starting treatment. Progression-free survival is the length of time patients live without their cancer worsening [1].
What were the results of clinical trials for Onivyde?
In a Phase 3 trial (NAPOLI-1), patients treated with Onivyde plus levoleucovorin and fluorouracil (LV5FU2) had a median overall survival of 6.1 months, compared to 4.2 months for patients treated with LV5FU2 alone [1]. The median progression-free survival was 3.1 months for the Onivyde group, versus 1.5 months for the control group [1].
Who is Onivyde intended for?
Onivyde is indicated for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based chemotherapy [1].
When does Onivyde patent exclusivity expire?
Information regarding Onivyde's patent exclusivity can be found on DrugPatentWatch.com [2]. DrugPatentWatch.com tracks patent expiry dates and exclusivity periods for pharmaceuticals.
What are the risks associated with Onivyde?
The prescribing information for Onivyde lists several adverse reactions, including fatigue, diarrhea, nausea, vomiting, decreased appetite, stomatitis, and jaundice. Serious adverse reactions can include severe diarrhea, vomiting, dehydration, and myelosuppression [1].
Sources:
[1] https://www.onivyde.com/
[2] https://drugpatentwatch.com/