An investigational pancreatic cancer drug that has not been approved by any regulator has now been distributed to physicians for more than 2,000 patients across nearly all 50 states and Puerto Rico, according to the company's second-quarter update. The disclosure is the first public measure of how widely daraxonrasib has been administered through the expanded access program since it opened in the spring.
Separately, the Food and Drug Administration has accepted the manufacturer's new drug application for review, moving the treatment from a compassionate use pathway toward a formal approval decision. Mark Goldsmith, chief executive of Revolution Medicines, described the period as one in which the company "rapidly translated unprecedented Phase 3 results for daraxonrasib into an active Expanded Access Program and the filing of our first New Drug Application."
