The U.S. Food and Drug Administration has approved an early access pathway for Revolution Medicines' investigational pill daraxonrasib, the company announced on Friday. The authorization permits certain patients with serious or life-threatening illnesses to receive the experimental therapy outside of clinical trials prior to full regulatory approval.
Revolution Medicines is studying daraxonrasib in people with metastatic pancreatic ductal adenocarcinoma - a form of pancreatic cancer that has spread beyond the pancreas - who have already undergone other treatments. The company said in April that daraxonrasib doubled survival compared with chemotherapy in a late-stage trial, a result that was followed by an uptick in the company's share price.
In addition to the pancreatic cancer program, daraxonrasib is being evaluated in late-stage clinical trials for non-small cell lung cancer. The drug has also been awarded an FDA priority review voucher, a regulatory mechanism intended to accelerate review of therapies addressing unmet medical need.
Revolution Medicines said it is working to launch the early access program in the U.S. as quickly as possible while emphasizing that rollout will prioritize patient safety and equitable access. Under FDA rules cited by the company, patients or caregivers cannot apply directly for access to the treatment. Instead, requests for early access must be submitted by a licensed treating physician.
The early access authorization provides a route for eligible patients with previously treated metastatic pancreatic ductal adenocarcinoma to obtain daraxonrasib outside a clinical trial setting. The company did not provide a specific timeline for opening the program, only that it is aiming to do so promptly and responsibly.
The authorization and the late-stage trial result that Revolution reported in April are the primary developments detailed by the company. No additional trial outcomes, expanded approvals, or broader availability timelines were provided in the announcement.
Summary of key developments
- FDA authorized an early access program for daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma.
- Revolution Medicines reported that daraxonrasib doubled survival versus chemotherapy in a late-stage pancreatic cancer trial, a disclosure that coincided with a rise in the company's share price.
- Daraxonrasib is also in late-stage trials for non-small cell lung cancer and has received an FDA priority review voucher.