Pancreatic cancer drug Onivyde approved by FDA but with a warning

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Onivyde (irinotecan liposome injection), manufactured by Merrimack Pharmaceutical Inc. was approved by the US Food and Drug Administration (FDA) Thursday but slaps a safety warning on the pancreatic cancer drug.  According to the agency in a press release, Onivyde comes with a health warning to health professionals that taking it comes with the risk of severe neutropenia (low white blood cell count) and diarrhea.

Onivyde can be taken in combination with fluorouracil and leucovorin to treat advanced pancreatic cancer patients who have undergone gemcitabine-based chemotherapy. According to Health Day, Onivyde can also cause severe inflammatory response and death in patients after taking the drug.

FDA's approval was based on the study of the drug's ability to extend survival rate among patients. Around 400 patients who have undergone gemcitabine-based chemotherapy were either given fluorouracil/leucovorin with Onivyde, Onivyde by itself or just fluorouracil/leucovorin. They found that the patients given the combination drugs lived an average of around six months. Those treated with fluorouracil/leucovorin only lived until four months, but there was no extended survival for Onivyde medication group.

FDA noted that the most common side effects of the treatment among patients include vomiting, fatigue, diarrhea, nausea, pyrexia, stomatitis, and low appetite.

Pancreatic cancer is considered to be one of the deadliest cancers in the United States, according to the American Cancer Society (ACS). The disease is estimated to affect nearly 49,000 men and women in US this year and more than 40,000 people will die from the disease. Some risk factors for pancreatic cancer include tobacco use, obesity, age, alcohol use and genetic syndromes.

Men are more susceptible to developing this cancer than women and African Americans have the highest risk of developing it among races. Heavy exposure to certain chemicals such as in dyes and pesticides can contribute to the risk for this disease.

It is unknown what causes pancreatic cancers but ACS states that like most cancers, it can be caused DNA mutations.

"Patients with metastatic pancreatic cancer or pancreatic cancer in general have very limited options," said study author Dr. Andrea Wang-Gillam from Washington University.

"These patients just simply don't do well," she explained via a report by Medscape. "This was a positive trial and will provide a new treatment option for patients with metastatic pancreatic cancer."

Reuters reports that pancreatic cancer is not easily discernible in its earlier stages.