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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.