RevMed’s experimental pancreatic cancer drug available via expanded access as FDA voucher program faces potential changes

RevMed's experimental pancreatic cancer therapy daraxonrasib has not received FDA approval yet, but the company is offering it through an expanded access (compassionate use) program.

Access to the drug remains limited, with patients encountering hurdles in obtaining it despite the program.

Meanwhile, the FDA's priority review voucher program, created under former FDA commissioner Marty Makary, may undergo revisions, raising questions about its future.

The article also notes that the U.S. Supreme Court upheld a key pathway for generic drug approvals, preserving an important mechanism for market competition.