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FDA expands access to promising drug for pancreatic cancer

The expanded-access program lets patients with no other options try the pill, which showed a 13-month median survival in a trial, Revolution Medicine said.

  • On Friday, the FDA authorized expanded access to daraxonrasib, allowing patients with metastatic pancreatic cancer who have exhausted other options to receive the treatment before official approval.
  • Drugmaker Revolution Medicine requested this 'compassionate use' access on April 28, following clinical trials showing the pill blocks the signal causing cancer cells to grow.
  • Reporting a 76% reduction in tumor volume, Former Sen. Ben Sasse called daraxonrasib "a miracle drug" in a conversation with "60 Minutes" after his diagnosis four months ago.
  • Clinical trials showed patients survived a median of 13 months on the drug compared to six months on chemotherapy, offering hope for pancreatic cancer with a five-year survival rate of about 13.7%.
  • FDA Commissioner Marty Makary said the timeline "reflects the FDA's strong commitment to facilitate early access" to therapies for serious conditions, expressing hope the action improves patients' lives.
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Seeking Alpha broke the news in United States on Friday, May 1, 2026.
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