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The US Food and Drug Administration announced today that it has approved a groundbreaking new treatment option for pancreatic cancer.
Manufactured by Revolution Medicines, daraxonrasib made headlines earlier this year when former US Sen. Ben Sasse, R-Neb., shared details about his experience with the drug — which left his skin bloody and “bubbling” but is also giving him more time with his family amid his battled with Stage 4 pancreatic cancer.
Clinical trial results showed that daraxonrasib, which will be sold under the brand name Rasonque, could double survival time for pancreatic cancer patients.
“This is life-altering,” Dr. 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.”
Patients taking the drug had a median overall survival of 13.2 months compared to 6.7 months for the chemotherapy group — a difference Dr. Nicholas Hornstein, a medical oncologist at Northwell’s Lenox Hill Hospital, called “remarkable.”
Rasonque is a tablet taken orally once a day. It worked by targeting a mutated protein called KRAS, which Hornstein said acts like a “stuck accelerator” in cancer cells, telling them to keep growing when they should stop.
“Scientists have been trying to block KRAS for decades with little success,” Hornstein said.
“Recent drugs have managed to target one specific faulty version of KRAS, but daraxonrasib appears to work across multiple versions, which means it could potentially apply to far more patients — and far more cancer types, including colorectal and lung cancer.”
However, a relatively common side effect of the drug is skin toxicity, which Sasse has experienced it.
The 54-year-old father of three, who was diagnosed last year, was candid about his health battle and treatment in an interview with the New York Times in April.
“I take it orally, but it’s a nasty drug,” he said. “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 added that his skin and face felt “nuclear.”
A pharmacist was so taken aback by his appearance asked if doctors had done something “electrical” to him.
“I don’t even know what that is, but either acid or electric shocks produce a face that looks this hideous,” Sasse said with a laugh.
Dr. Hornstein qualified that the toxicity is “generally far less than what Mr. Sasse reported.”
“Additionally, involving onco-dermatology early and using some newer agents, we are having significant success in mitigating these side effects,” he said.
Acting FDA Commissioner Kyle Diamantas said today that the new drug approval “provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.”
“It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” he added. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”
English (US)