FDA approves pancreatic cancer drug that extends patients’ lives

Live updates

1. 1h ago

   FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer

   The FDA approved daraxonrasib, an oral multi-selective RAS(ON) inhibitor, for adults with metastatic pancreatic adenocarcinoma. The drug targets patients who have already undergone at least one systemic therapy or those ineligible for multiagent systemic therapy. Developed through efforts involving the University of Cincinnati and Dana-Farber, the medication addresses a previously undruggable target. Clinical data indicates the drug nearly doubles median survival from 6.7 months to 13.2 months and blocks tumor growth in over 90% of cases.

   Why it matters

   Pancreatic cancer has a high mortality rate, with 97% of patients dying within five years. This approval provides a first-of-its-kind treatment option for patients whose cancer has spread and progressed despite previous interventions.

   What is confirmed

   • The FDA approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma.
   • Daraxonrasib is an oral multi-selective RAS(ON) inhibitor.
   • The drug is for patients who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
   • University of Cincinnati researchers helped develop the treatment.

   Still unconfirmed

   • Clinical trials showed the drug nearly doubled median survival from 6.7 months to 13.2 months.
   • The medication blocks tumor growth in more than 90% of cases.
   • High costs of the drug have caused affordability debates in India.

   What to watch next

   • Data on long-term survival rates beyond the initial trial period
   • Pricing and insurance coverage decisions in the US
   • Clinical results for daraxonrasib as a first-line therapy
   Sources used for this update (5)

   1. www.news-medical.net — FDA approves daraxonrasib for metastatic pancreatic cancer following landmark clinical trial led by Dana-Farber
   2. www.news-medical.net — FDA approves daraxonrasib for patients with metastatic pancreatic cancer
   3. www.yahoo.com — INTERVIEW: Yale doctor discusses new pancreatic cancer drug
   4. www.cancertherapyadvisor.com — Tumor Treating Fields Extend Survival, but Uptake Has Been Slow
   5. www.wcpo.com — 'This is the beginning’ | UC researchers helped tackle an ‘undruggable’ target in pancreatic cancer
   confidence 90%
2. 3d ago

   FDA Approves Daraxonrasib Pill for Advanced Pancreatic Cancer

   The FDA granted expedited approval to Rasonque, a daily oral RAS inhibitor developed by Revolution Medicines and the University of Cincinnati Cancer Center for adults with advanced pancreatic cancer. Clinical trials showed the drug nearly doubled median survival from 6.7 months to 13.2 months. The medication blocks tumor growth in more than 90% of cases. While the drug offers a new treatment path for a disease where 97% of patients die within five years, its high cost has sparked affordability debates in India.

   Why it matters

   Pancreatic cancer is one of the deadliest malignancies with historically limited treatment options for metastatic stages. This approval marks the first pill capable of extending survival for this patient population.

   What is confirmed

   • The FDA approved daraxonrasib, marketed as RASONQUE, for adults with advanced pancreatic cancer.
   • Clinical trials showed median survival increased to 13.2 months from 6.7 months.
   • The medication is a once-daily oral RAS inhibitor.
   • The drug was developed by Revolution Medicines and the University of Cincinnati Cancer Center.

   Still unconfirmed

   • The drug blocks tumor growth in more than 90% of pancreatic cancer cases.
   • A month's supply of the drug costs nearly Rs 38 lakh in India.

   What to watch next

   • Pricing and insurance coverage determinations in the United States.
   • Long-term survival data beyond the initial clinical trial period.
   Sources used for this update (8)

   1. www.yahoo.com — Groundbreaking pancreatic cancer drug approved by FDA: What we know
   2. san.com — FDA approves pancreatic cancer drug tested on former lawmaker
   3. medicalxpress.com — FDA approval opens new chapter in pancreatic cancer treatment
   4. www.dynamitenews.com — New Pancreatic Cancer Pill Doubles Survival, But Rs 38 Lakh Price Sparks Debate in India
   5. www.rttnews.com — Weekly Buzz: GILD, ROIV Win FDA Nod; BHVN, LLY Strike Deal; SYRE Misses Monotherapy Goal
   6. www.gastroenterologyadvisor.com — FDA Approves First Pill to Extend Survival In Advanced Pancreatic Cancer
   7. www.bendsource.com — St. Charles Offers Groundbreaking Pancreatic Cancer Medication
   8. thetimesweekly.com — FDA approves breakthrough pancreatic cancer drug – an oncologist explains how daraxonrasib nearly doubles survival
   confidence 95%
3. 4d ago

   FDA approves RASONQUE pancreatic cancer drug after survival rates nearly double

   The FDA has approved daraxonrasib, marketed as RASONQUE, a targeted once-daily pill for advanced pancreatic cancer. The drug was approved more than six months ahead of schedule following trials that nearly doubled median survival to 13.2 months, compared to 6.7 months for patients receiving chemotherapy. Developed by Revolution Medicines with assistance from the University of Cincinnati Cancer Center, the medication is described as a breakthrough for a disease traditionally considered intractable. Anna Berkenblit of the Pancreatic Cancer Action Network stated the organization has never seen a benefit of this magnitude.

   Why it matters

   Pancreatic cancer is a deadly disease with historically limited treatment options. This approval introduces a targeted therapy designed to extend the lives of patients with advanced stages of the malignancy.

   What is confirmed

   • The FDA approved daraxonrasib, sold under the brand name RASONQUE, for the treatment of pancreatic cancer.
   • Clinical trials showed the drug nearly doubled median survival to 13.2 months from 6.7 months seen with chemotherapy.
   • The medication is a targeted therapy administered as a once-daily pill.
   • Revolution Medicines developed the drug with help from the University of Cincinnati Cancer Center.
   • The FDA issued the approval more than six months earlier than scheduled.

   Still unconfirmed

   • Former UF President Ben Sasse credits the drug with extending his life.
   • A stage 4 patient in Maine reports the pill is buying him more time.

   What to watch next

   • Long-term survival data beyond the initial trial period
   • Availability and insurance coverage for RASONQUE in the U.S.
   • Development of similar targeted medicines for other pancreatic cancer mutations
   Sources used for this update (19)

   1. WSJ — FDA Approves Drug for Pancreatic Cancer in Incredible Moment for Deadly Disease
   2. The New York Times — F.D.A. Approves Drug Poised to Transform Care for Pancreatic Cancer
   3. CNN — Revolution Medicines gets FDA nod for targeted pancreatic cancer drug
   4. Bloomberg — A Breakthrough Pancreatic Cancer Drug Marks a New Era for Treatment
   5. The Washington Post — FDA approves ‘landmark’ pancreatic cancer drug that extends patients’ lives
   6. Reuters — Revolution's lifesaving pancreatic cancer drug wins speedy FDA approval
   7. Fox News — FDA approves once-daily pill for deadly cancer after patients' survival rates nearly double
   8. Scientific American — U.S. approves breakthrough pancreatic cancer drug, heralding a new era for an intractable disease
   9. WSJ — Opinion | A Pancreatic Cancer Revolution
   10. BBC — FDA approves breakthrough drug daraxonrasib to treat pancreatic cancer
   11. WGME — Stage 4 Maine cancer patient says new FDA-approved pill is buying him time
   12. Pancreatic Cancer Action Network — FDA Approves RASONQUE™ (daraxonrasib)
   confidence 95%