The FDA approved daraxonrasib to treat metastatic pancreatic cancer in patients who have already undergone chemotherapy.

The FDA approved daraxonrasib, sold under the brand name Rasonque, to treat metastatic pancreatic adenocarcinoma in patients who have previously undergone chemotherapy. The drug, a once-daily pill, is the first treatment to target a mutation on the KRAS gene, which is found in most pancreatic cancer patients.

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In Phase 3 clinical trials, daraxonrasib increased the median overall survival time to 13.2 months, compared to 6.7 months for patients taking standard chemotherapy. The drug also improved progression-free survival, doubling it from 3.5 months to 7.3 months. Patients receiving daraxonrasib showed a favorable tolerability profile, with fewer grade 3 or higher adverse events and lower treatment discontinuation rates due to toxicity compared to chemotherapy. Daraxonrasib uses a tri-complex mechanism to inhibit multiple RAS mutations. This broader activity makes it relevant for pancreatic cancer, where G12X mutations predominate. While the drug is currently authorized for late-stage patients, ongoing studies are evaluating its effectiveness as a first-line treatment and in combination with chemotherapy for various cancers, including lung and ovarian cancers.

Sources

• Healthcare Brew
  Oncologists say newly approved pancreatic cancer drug is a breakthrough for treatment
• Hospital Pharmacy Europe
  Cracking the ‘undruggable’: daraxonrasib and precision oncology

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Paywall and unreadable sources

• STAT
  A breakthrough pancreatic cancer drug won approval. They still struggle to access it
• The Cancer Letter
  As daraxonrasib hits the clinic, Frank McCormick says RAS is bigger than pancreatic cancer
• CancerNetwork
  Daraxonrasib Yields Activity in Previously Treated RAS-Mutant NSCLC