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FDA fast-tracks pancreatic cancer drug daraxonrasib
Family and emergency medicine physician Dr.Janette Nesheiwat discusses how artificial intelligence could help detect pancreatic cancer earlier and the FDA fast-tracking the drug daraxonrasib on �’
A new drug forpancreatic canceris showing promise in early testing.
Daraxonrasib is a daily pill designed to block cancer signals linked to the RAS gene.It has now finished an early-stage clinical trial — the first time it was tested in people — to evaluate both its safety and effectiveness.
The clinical trial, led by the Dana-Farber Cancer Institute and published in The New England Journal of Medicine, tested the drug in 168 patients with advanced pancreatic cancer whose tumors had mutations in the RAS gene.All study participants had previously received at least onechemotherapy treatment.
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The drug is designed to block multiple activecancer signalsthat help tumor cells grow.This is especially important because more than 90% of pancreatic cancers carry these harmful mutations, researchers said.
Existing and older drugs that target RAS mutations only work on certain types that are uncommon in pancreatic cancer, such as KRAS mutations.

Daraxonrasib is a daily pill designed to block cancer signals linked to the RAS gene.It has now finished an early-stage clinical trial to evaluate its safety and effectiveness.(iStock)
At the 300-milligram dose — the amount that will be used in larger phase 3 trials — about 30% of patients saw a positive response, researchers noted.Overall, about 90% of patients had their cancer either shrink or stop getting worse.
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There were some side effects reported — most commonly rash, mouth inflammation, nausea and diarrhea.
Lead investigator Dr.Brian Wolpin, director of the Hale Family Center for PancreaticCancer Researchat Dana-Farber, commented in a press release statement that this development could change the future of cancer care.

About 90% of patients treated with the drug experienced disease control, meaning their cancer was reduced or stabilized.(iStock)
“If supported by data from futureclinical trials, daraxonrasib would be a targeted therapy relevant to nearly all patients with advanced pancreatic cancer,” he said.
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“This trial provides the first published data showing the safety and broad activity of a RAS(ON) multi-selective inhibitor in pancreatic cancer,” Wolpin went on.“If it proves effective in larger clinical trials, it would signify a substantial shift in how this disease is treated.”
�one of the most promising therapy advances we’ve seen inpancreatic cancer.”
effective therapies” in the past, Wolpin noted.
“The study also showed disease control in approximately 90% of patients withmetastatic pancreatic cancer, which is extremely exciting,” he added.

The study does not prove daraxonrasib is superior to standard treatment of chemotherapy, researchers noted.(iStock)
Wolpin noted that while side effects were common, most patients were able to tolerate treatment with “supportive care measures, and very few patients needed to stop therapy due to side effects.”
As this was a phase 1/2 study, it does not “definitively prove” the superiority of daraxonrasib compared to chemotherapy, Wolpin added.

“Additional research is needed to determine how best to sequence or combine therapies to provide the most durable responses and cures,” the lead investigaror sid.(iStock)
For patients and families affected by pancreatic cancer, Wolpin noted that daraxonrasib signals “real momentum” toward effective treatments, but it is still investigational and is not a cure.
“Pancreatic cancer remains a challenging disease, and additional research is needed to determine how best to sequence or combine therapies to provide the most durable responses and cures,” he said.
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Brian Slomovitz, director of “Doubling the survival time in pretreated patients is unprecedented.” “If the full dataset results that will be reported later this month confirm what was earlier released, I believe this will be one of themost important breakthroughsin all solid tumors,” Slomovitz went on.“Doubling the survival time in pretreated patients is unprecedented.” TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ The doctor added that the “magnitude of benefit” could “reshape the treatment landscape” and “establish a new standard of care.” “We will need to evaluate the full dataset for efficacy and safety,” Slomovitz added.“I am more than cautiously optimistic, and I am truly excited for our patients and their families that suffer from this dreadful disease.”
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