Revolution Medicines has initiated shipment of daraxonrasib, an experimental pancreatic cancer treatment, through an FDA-authorized expanded access program while preparing for formal regulatory submission. The drug represents a significant advancement in precision oncology, specifically targeting KRAS G12C mutations found in approximately 2% of pancreatic adenocarcinomas. This compassionate use pathway allows patients with advanced disease who have exhausted standard treatment options to access the investigational therapy months before potential FDA approval. CEO Mark Goldsmith announced that the company plans to submit daraxonrasib for regulatory approval in the coming months, supported by promising efficacy and safety data presented at the American Society of Clinical Oncology annual meeting. The expanded access program underscores the company’s confidence in the drug’s clinical profile and addresses a critical need in pancreatic cancer treatment, where five-year survival rates remain at 12% across all disease stages. Read the full article on GMJ Newsroom.
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