FDA approves new pancreatic cancer treatment

Merrimack Pharmaceutical Inc.’s pancreatic cancer therapy “Onivyde” has gained approval by the U.S. Food and Drug Administration. They further went ahead to say that it was not recommended to be used as a single agent. “We applaud the dedication of those involved in this advancement, knowing it will impact our goal to double pancreatic cancer survival by 2020”.

Approximately 49,000 individuals are diagnosed with pancreatic cancer each year in the United States, the overwhelming majority of whom have adenocarcinoma.

Pancreatic cancer is hard to diagnose early and there are limited treatment options, especially when it has spread to other parts of the body and surgery to remove the tumor is not possible, the FDA said in the news release. Most time, it is not quickly detected during its early stages and it has accounted for 7 percent of cancer deaths in the United States, based on statistics from American Cancer Society. Patients were randomly assigned to receive Onivyde with fluorouracil/leucovorin, Onivyde alone, or fluorouracil/leucovorin alone.

Onivyde was granted both Priority Review and orphan drug designation by the regulatory authority.

The researchers found that people treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin, the FDA said.

While Merrimack has a $1.1 billion market cap, at least ahead of the news, this could be a big gain for the company. The study evaluated whether Onivyde plus leucovorin/fluorouracil or Onivyde alone improved survival than when patients were treated with leucovorin/fluorouracil alone.

In regard to safety, the most common side effects of treatment with liposomal irinotecan are diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, and pyrexia.

The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks for severe neutropenia and diarrhea. The drug may also cause lymphopenia and neutropenia in a few patients and sepsis-related death following neutropenia has been reported in patients treated with the drug.