Newly approved cancer drug targets aggressive form of ‘deadly disease’

A new drug regimen for certain types of pancreatic cancer recently received approval from the U.S. Food and Drug Administration (FDA) — the first new medication in nearly a decade.

Onivyde (irinotecan liposome), an injectable medication made by Ipsen, has been approved for use along with oxaliplatin, fluorouracil and leucovorin as a regimen for patients with metastatic pancreatic adenocarcinoma (mPDAC).

This type of cancer is an aggressive malignancy with an average life expectancy of between eight and 11 months, according to the National Institutes of Health (NIH).

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The approval was based on a randomized, controlled trial that included 770 patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy, according to an FDA press release.

The group of patients who received the new regimen via IV infusion showed “significant improvements” in survival rates and response rates compared to the control group.

The drug regimen is administered via IV for 90-minute sessions every two weeks.

“I am hopeful that this regimen represents a new reference — meaning we will add to this in the future,” Dr. Zev Wainberg, professor of medicine and co-director of the UCLA GI Oncology Program in Los Angeles, told Fox News Digital.

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“We needed clarity on the data before proceeding, which the Phase 3 trial provides.”

Metastatic pancreatic cancer is one of the most difficult cancers to treat, Wainberg noted, as it doesn’t respond as well to new drugs that work in other types of the disease. 

“Patients are unfortunately often quite sick, and many cancers move too fast for a drug to work as they might in other cancers,” he noted.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, said the drug is “a useful new tool, but not a game-changer.”

“It works well in conjunction with other chemotherapies that have been used for widespread pancreatic cancer,” Siegel told Fox News Digital. 

“It works by interfering with DNA replication in the cancer and by damaging the tumor’s DNA repair.”

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Dr. Peter Hosein, M.D., associate director of clinical research at the University of Miami’s Sylvester Comprehensive Cancer Center’s Pancreatic Cancer Research Institute, also commented on the new approval.

“Pancreatic cancer is a deadly disease where meaningful progress is sorely needed in prevention, early detection and treatment to improve outcomes,” he told Fox News Digital.

Onivyde is a new formulation of an old drug that is “almost identical,” Hosein said.

“So, although this is a new approval, it does not really represent meaningful progress,” he told Fox News Digital. 

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Onivyde is also “substantially more expensive” than Irinotecan, the existing standard medication, Hosein pointed out. 

“There are many doctors and scientists working around the clock on this disease and the survival rates are slowly improving,” he said. 

“We need to continue focusing on breakthrough therapies that will truly move the needle to help our patients.” 

The most commonly reported side effects of Onivyde are diarrhea, nausea, vomiting, fatigue, decreased appetite, abdominal pain, mucosal inflammation, constipation and weight loss, the FDA stated. 

“All drugs have a safety profile that needs to be taken seriously,” Wainberg said. 

“Here, most of the combination produced GI upset — diarrhea and sometimes dehydration — so prophylactic (preventative) management is critical.”

Fox News Digital reached out to Ipsen, a French biopharmaceutical company headquartered in Paris, France, for additional comment.

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