A clinical trial showed a pill almost doubled survival for people with stage four pancreatic cancer. Can patients access the medication now? How long until the FDA can approve it? Here are some answers.
This undated microscope image from USC via the NIH shows pancreatic cancer cells, nuclei in blue, growing as a sphere encased in membranes, red. An experimental pill to treat metastatic pancreatic cancer almost doubled patients’ survival times compared with chemotherapy.
The drug isn’t Food and Drug Administration approved, so it’s not readily available for all patients. Some eligible patients might be able to get the medication before it is FDA approved using a special program for people with life-threatening diseases.available in the disease’s early stages.
Even though just 3.2% of newly diagnosed cancers are pancreatic, it is the nation’s So when Dr. Rachna Shroff, who has been treating pancreatic cancer patients for 16 years, saw promising findings from a recently published clinical trial, she felt what she described as a monumental shift.
"The data brought tears to my eyes," said Shroff, the University of Arizona Cancer Center’s chief of hematology and oncology.that an experimental pill from the company Revolution Medicines almost doubled metastatic pancreatic cancer patients’ survival times compared with chemotherapy. What happens next will determine whether and when patients may be able to access the drug, daraxonrasib . Here’s what these findings could mean for patients in the near future.
, a phase 3 clinical trial, involved 500 metastatic, or stage four, pancreatic cancer patients who had already received a first-line treatment such as chemotherapy. After the initial treatment stopped working or proved unsuccessful, the patients were randomly assigned to receive either the daraxonrasib pill once daily, or a Among patients who took daraxonrasib, the median overall survival time was 13.2 months — almost twice chemotherapy’s median overall survival time of 6.7 months.
Chemotherapy is administered to a cancer patient via intravenous drip in Durham, N.C. on Sept. 5, 2013. Right now, the drug is an option for pancreatic cancer patients who have already received some kind of treatment. But researchers are alsoThe genetic factors of a patient’s cancer might also affect whether daraxonrasib is a suitable treatment option. The National Comprehensive Cancer Network’s guidelines urge people to get tested for genetic mutations specific to their pancreatic cancer.
This helps doctors determine the best treatment options and clinical trial eligibility as treatments are tested and clinical guidelines evolve, Shroff said.
"There are so many drugs beyond daraxonrasib" being tested, Shroff said, including those that target the cancer’s specific genetic mutations. Plus, with pancreatic cancers that have certain genetic mutations, there might be existing FDA-approved drugs that are the best treatment option.investigational drugs if they are ineligible for — or cannot access — clinical trials and have no other comparable treatments available to them.
A doctor who believes a patient would be a good candidate for"compassionate use" of daraxonrasib can submit paperwork to Revolution Medicines, the FDA and an ethics committee or institutional review board requesting approval. Sometimes patients must cover the It’s unclear how many patients are seeking access to daraxonrasib through the"compassionate use" program. Revolution has not said how many people are expected to receive daraxonrasib via expanded access.
Demand is already high, and the company said it expects it to remain that way. Shroff said as soon as it was possible to do so, she and her colleagues at the University of Arizona Cancer Center began theof requesting that their patients be considered. As of June 2, she said her patients hadn’t received the pill. It’s hard to know for sure because the FDA will set the timeline.
But Dr. Daniel King, a gastrointestinal medical oncologist at the Northwell Health Cancer Institute in New York, said it could be approved as soon as the fourth fiscal quarter, which includes October, November and December. Shroff also guessed it could be a matter of months. , the agency said it was including daraxonrasib in a pilot program that aims to speed up FDA reviews.
The FDApilot program participants would receive a decision one to two months after a drug company’s complete application is filed.the cost of investigational medications that patients can get with special approval, but the company providing the treatment can choose to provide it at no cost. Doctors said they expect major insurers will cover daraxonrasib, once approved. While 11.2% of patients stopped chemotherapy treatment because of side effects, only 1.2% of those on daraxonrasib stopped taking the medication for that reason.
Once the pill is widely available for patients, Shroff said physicians will continue to work across disciplines — with dermatologists to treat the skin reaction, for example — to make sure patients can tolerate the medication. Interview with Dr. Rachna Shroff, the division of hematology/oncology chief at the University of Arizona Cancer Center, June 2, 2026 Interview with Dr. Daniel King, a gastrointestinal medical oncologist at the Northwell Health Cancer Institute in Lake Success, NY, June 1, 2026 “No están recibiendo el entrenamiento tradicional de cinco meses… .
El entrenamiento para los agentes de ICE ahora es de 47 días”. There was not “a single, prominent conservative voice in the country that even remotely wanted or hoped or was pushing to get Jimmy Kimmel taken off the air. ” "The number of New Yorkers who consume cannabis daily or near daily is the same as the number of New Yorkers who buy coffee from a coffee shop daily or near daily — 1.2-plus million people.
" "Michigan has spent more than $2.5 billion on incentives to companies since 2019, and so far, that fund, the SOAR fund, has created zero jobs. " El presidente Donald Trump firmó una ley para aumentar el salario mínimo a $25 la hora y entra en vigor el 1 de junio. “The reason are forced to survive 22 hours a day without electricity is not due to an oil ‘blockade’ by the US. ”
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