Can Onivyde be used for pancreatic cancer?

What is Onivyde, and where is it approved for use?

Onivyde (iplatinib) is a chemotherapy medication approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of patients with metastatic pancreatic cancer in combination with a 5-fluorouracil (5-FU) and leucovorin (LV). Additionally, in 2016, the FDA expanded its approval to include patients with locally advanced pancreatic cancer in combination with 5-FU and LV.

What studies have evaluated Onivyde's effectiveness in pancreatic cancer?

According to the National Cancer Institute, the approval of Onivyde for pancreatic cancer was based on the results of the NAPOLI-1 trial, which was a randomized phase III clinical study. The study compared the efficacy and safety of Onivyde, 5-FU, and LV combination therapy to 5-FU and LV alone in patients with metastatic or locally advanced pancreatic cancer. Results showed that Onivyde, 5-FU, and LV combination therapy significantly improved overall survival compared to 5-FU and LV alone in patients with metastatic pancreatic cancer.

https://www.cancer.gov/about-cancer/treatment/diet-nutrition/drugs/onivyde

How does Onivyde compare with other pancreatic cancer treatments?

According to studies, Onivyde is often used as a second-line treatment for patients with pancreatic cancer who have already received chemotherapy. Studies have shown that Onivyde has similar efficacy to other chemotherapy agents, such as gemcitabine, in patients with metastatic pancreatic cancer.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4344451/

What side effects are associated with Onivyde use in pancreatic cancer?

Common side effects of Onivyde include low white blood cell count, low red blood cell count, fatigue, nausea, and vomiting. Additionally, patients with pancreatic cancer treated with Onivyde have a higher risk of developing infusion-related reactions, which may include symptoms such as nausea, vomiting, diarrhea, and rash.

What are the patent details and exclusivity status for Onivyde in the treatment of pancreatic cancer?

According to DrugPatentWatch.com, the US patent for Onivyde (iplatinib) was granted to Merrimack Pharmaceuticals in 2014, with a term ending in 2031. Exclusivity for Onivyde in the metastatic pancreatic cancer indication expires in 2026, with the locally advanced pancreatic cancer indication expiring a bit later.

https://www.drugpatentwatch.com/drug/ipatinib

Sources:

1. National Cancer Institute. (2022). Pancreatic Cancer Treatment.
2. Merrimack Pharmaceuticals. (n.d.). Onivyde (Iplatinib).
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4344451/