‘Life-altering’: FDA approves pancreatic cancer drug

The U.S. Food and Drug Administration on Wednesday approved a new drug for advanced pancreatic cancer, a milestone in the treatment of one of the most deadly types of tumors.

FDA officials gave expedited approval to the pill, called daraxonrasib, The New York Times reported. The drug, manufactured by Revolution Medicines, will be sold under the brand name Rasonque, according to the newspaper.

The drug was approved for patients who have metastatic pancreatic cancer and have already tried chemotherapy, the Times reported. It will cost approximately $39,800 for a month’s supply, according to The Associated Press.

The drug blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases, the news organization reported. The drug, taken twice a day in pill form, is not a cure, but it is the first treatment to dramatically extend the lives of patients with pancreatic cancer, according to the Times.

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“This is life-altering,” Carla Kurkjian, an oncologist at Mercy Hospital in Oklahoma City, told The Wall Street Journal. “Not just for patients, as far as helping them extend their lives beyond anything we’d ever seen, but for us as physicians, to be able to have a different conversation than we’ve had for so long.”

In a key clinical trial, participants who took daraxonrasib lived for a median of more than 13 months, compared with less than seven months for those who received chemotherapy, according to the Times. Some patients who have gotten the drug through clinical trials have lived for years.

“We’ve never seen a benefit like this,” Anna Berkenblit, the chief scientific and medical officer at the Pancreatic Cancer Action Network, an advocacy group for research and patients, told the newspaper.

The cost of taking the drug for a full year is approximately $478,000, the Times reported. The majority of the cost is expected to be covered through insurance, with varying out-of-pocket costs for patients, according to the newspaper.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer, acting FDA Commissioner Kyle Diamantas said in a statement. ”It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”

The drug has side effects, according to The Wall Street Journal. Patients could experience a rash across the body and gastrointestinal issues. Former U.S. Sen. Ben Sasse of Nebraska, who went public and described a significant reduction in his tumors while in a clinical trial, appeared on television with his face covered in red blotches, the newspaper reported.

Still, the drug provides hope for patients who have viewed pancreatic cancer as a swift death sentence.

“This is a monumental opportunity for patients and their families, and we need to do everything we can to clear the decks and make that happen as quickly as possible,” Revolution Medicine Chief Executive Mark Goldsmith told The Wall Street Journal.

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