The Food and Drug Administration (FDA) approves a new pancreatic cancer drug for use but cautions patients and prescribers to take note of the boxed warnings that come with the product.

On Oct. 22, FDA has approved the use of Onivyde, an irinotecan liposome injection drug, in combination with leucovorin and fluorouracil as a chemotherapeutic option for patients with advanced pancreatic cancer who were no longer responsive to gemcitabine-based treatments.

This is a significant improvement because not only is pancreatic cancer regarded one of the deadliest cancers in the world due to being difficult to diagnose early, but also because of the limited treatment options available.

"Many FDA staff 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," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products and part of the FDA's Center for Drug Evaluation and Research.

Onivyde's manufacturers, Merrimack Pharmaceuticals, are equally elated at the approval of their new drug for public use.

"We are thrilled to be able to deliver this groundbreaking therapy to patients battling metastatic pancreatic cancer," said Robert Mulroy, CEO-President of the company. "Today's approval by the FDA is a pivotal milestone in our company's history, representing years of hard work and commitment to our mission of engineering new treatment options for cancer patients in need."

Onivyde's effectiveness was evaluated based on the results of a randomized, three-arm study on more than 400 patients with metastatic pancreatic cancer. Study results showed that patients treated with a combination of Onivyde and fluorouracil/leucovorin lived by an average of 6 months longer compared to those treated with only fluorouracil/leucovorin or Onivyde alone.

Patients who were treated with the Onivyde-fluorouracil/leucovorin combination were found to have a delayed tumor growth time compared to other participants in the trial.

When it comes to safety, however, Onivyde, like most chemotherapeutic drugs, comes with many side effects. Based on patient evaluation, common side effects include diarrhea, nausea and vomiting, fatigue, anorexia, stomatitis (inflammation of the mouth), immunosupression and fever.

 There is also a risk for decreased kidney function, sepsis (life-threatening infection) and death for patients using Onivyde. With these in mind, labels for Onivyde are required to include boxed warnings to alert prescribers on the risks for diarrhea and severe neutropenia. Onivyde is also not meant to be used as a singular chemotherapeutic agent.

Photo: Stephen Dickter | Flickr

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