FDA approves use of new Pancreatic Cancer Drug
The Food and Drug Administration (FDA) permitted the use a new pancreatic cancer drug, but has spread awareness among patients and prescribers to note down the list of warnings that comes along with the product.
This is a major advancement because pancreatic cancer is regarded as the most fatal cancers in the world, and its diagnose is very difficult to find early and only few treatment options are available.
Director of the Office of Hematology and Oncology Products and part of the FDA's Center for Drug Evaluation and Research, Dr. Richard Pander said, “Many FDA staffs who review drug applications are clinicians as well, so it's especially rewarding when we are able to expedite access to new treatments for patients with unmet needs”.
Merrimack Pharmaceuticals, Onivyde’s manufacturer, is ecstatic about the approval by FDA for their new drug. Robert Mulroy, CEO-President of the company, said that they are elated about the fact that their company got the approval for their new drug. The company is happy to distribute this therapy to patients fighting metastatic pancreatic cancer.
Three-arm study was conducted which included around 400 patients with metastatic pancreatic cancer and on that basis effectiveness of Onivyde was assessed. The results of the study revealed that the patients with an amalgamation of Onivyde and fluorouracil/leucovorin survived longer by an average of 6 months in comparison with those treated with of Onivyde and fluorouracil/leucovorin.
There are certain side effects of the drug similar most chemotherapeutic drugs that include fatigue, anorexia diarrhea, nausea and vomiting, immunosupression, stomatitis (inflammation of the mouth) and fever.