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FDA approves Rasonque for pancreatic cancer; lung cancer use

Updated 9 times since CLSTR started tracking revisions of this situation.

What changed

2026-08-31 07:55 UTC → 2026-09-04 02:44 UTC · added removed

FDA approves Rasonque for advanced pancreatic cancer; lung cancer use

On 26 August 2026, the U.S. Food and Drug Administration (FDA) granted expedited approval to daraxonrasib, marketed under the brand name as Rasonque, for treating adults with metastatic pancreatic ductal adenocarcinoma (PDAC). Developed by Revolution Medicines, this once-daily oral pill is the first targeted therapy approved to inhibit the RAS protein, a molecular driver present in approximately 90% to 95% of pancreatic cancer cases. The approval follows results from the Phase III RASolute 302 trial, which involved 500 patients. The study showed that patients receiving Rasonque achieved a median overall survival of 13.2 months, compared to 6.7 months for those receiving standard or investigator-choice chemotherapy. This represents a 60% reduction in the risk of death and a doubling of median progression-free survival (7.2 months versus 3.6 months). Clinical data also indicated an objective response rate of 30%, compared to 11% in the control group. survival. The therapy has demonstrated efficacy across major oncogenic variants, including KRAS G12D, G12V, and G12R mutations, addressing a target previously considered ‘undruggable’. The FDA granted approval through Breakthrough Therapy and Orphan Drug designations, utilizing Real-Time Oncology Review to complete the process approximately 6.5 months ahead of the standard deadline. Rasonque is indicated for patients who have progressed after initial chemotherapy or are ineligible for multiagent systemic therapy. Experts note that while While approved in the therapy is a significant advancement for one of U.S., the most aggressive forms of cancer, it is not a cure but drug remains investigational elsewhere; the European Medicines Agency (EMA) has initiated a means phased review to extend life and slow disease progression. Reported common side effects include skin rash, diarrhea, nausea, vomiting, fatigue, determine future availability in Europe and mouth sores. In the U.S., Nordic regions. Beyond pancreatic cancer, clinical trial data published in the New England Journal of Medicine indicates that daraxonrasib shows promise in treating advanced non-small cell lung cancer (NSCLC) with RAS mutations. In a 30-day supply Phase 1/2 trial of patients previously treated with platinum-based chemotherapy and immunotherapy, researchers observed an objective response rate of 42% in a specific cohort. The therapy is expected to cost approximately $39,800. currently advancing through the Phase 3 RASolve 301 trial for this indication.

Versions

  1. 2026-09-04 02:44 UTC FDA approves Rasonque for pancreatic cancer; lung cancer use
  2. 2026-08-31 07:55 UTC FDA approves Rasonque for advanced pancreatic cancer
  3. 2026-08-29 00:36 UTC FDA approves Rasonque for advanced pancreatic cancer
  4. 2026-08-28 21:05 UTC FDA approves Rasonque for advanced pancreatic cancer
  5. 2026-08-28 19:50 UTC FDA approves Rasonque for advanced pancreatic cancer
  6. 2026-08-28 10:18 UTC FDA approves Rasonque for advanced pancreatic cancer
  7. 2026-08-27 19:54 UTC FDA grants expedited approval for daraxonrasib
  8. 2026-08-26 17:27 UTC FDA grants expedited approval for daraxonrasib
  9. 2026-08-14 20:15 UTC Daraxonrasib trial shows doubled survival, EMA review on-go
  10. 2026-08-01 01:01 UTC Daraxonrasib trial shows doubled survival, EMA review ongo‑g

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