In a groundbreaking move, the Food and Drug Administration has approved a new drug to treat advanced pancreatic cancer. It’s a major win for Americans suffering from what’s long been considered the most incurable forms of cancer.
The FDA on Wednesday gave expedited approval to daraxonrasib, a landmark pill that’s been found to block tumor growth in more than 90% of pancreatic cancer cases.
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Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S., according to the Hirschberg Foundation for Pancreatic Cancer Research. It’s especially deadly because it often goes unnoticed until symptoms start to appear in its later stages. Unlike other cancers, there’s no routine screening.
And once it’s detected, there aren’t many effective treatments — until now.
What is daraxonrasib?
Daraxonrasib, which will be sold under the brand name Rasonque, is made by Revolution Medicines. It’s been approved for patients with metastatic pancreatic cancer who have already tried chemotherapy.
It first gained notoriety when former Sen. Ben Sasse shared a photo of himself on social media in which he was suffering side effects from the then-experimental drug.
In an interview with The New York Times in April, Sasse said that when he was first diagnosed, he was in a great deal of pain.
“I was in a ton of pain early on because I had some pancreatic tumors that were essentially pushing on my spinal column,” Sasse said. “The liver and pancreas are at the rib cage in the front, and they’re pushing out the back into my spine.”
Sasse said he was taking 55 milligrams of morphine a day and was “high as a kite.”
“But since then, the drug [daraxonrasib] has shrunk the tumors so much that I was willing to dial back up a little bit of pain to get a little bit of energy back and to be able to have a little more control of my nausea, et cetera,” he said at the time. “I’m down to only about 30 milligrams a day of morphine. I’d say my pain is 80 percent reduced from where I started.”
According to Mayo Clinic, the typical limit of oral morphine dose in a day is 20 milligrams.
Sasse also said while he’s grateful for the treatment and as of April his tumors had shrunk by about 76%, daraxonrasib is a “nasty drug.”
“It causes crazy stuff, like my body can’t grow skin and so I bleed all out of a whole bunch of parts of me that shouldn’t be bleeding,” he said.
How well does it work?
The company says that while the medicine is not a cure, it can significantly extend the lives of pancreatic cancer patients.
In a clinical trial, those taking daraxonrasib lived for a median of more than 13 months, a significant improvement over the less than seven months for those who underwent chemotherapy, according to the drugmaker. Revolution Medicines says some patients taking their twice-a-day pill during the clinical trials have even lived for years.
The drug will go for $39,800 a month — or about $478,000 for a full year. Insurance is expected to cover most of the costs. It’s not yet clear how much patients will be responsible for.
More than 2,000 patients have already gotten early access to the drug for free through an expanded access program. Revolution Medicines says it will now transition to getting the drug covered through insurance.
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