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FDA OKs Expanded Access to Revolution’s Pancreatic Cancer Drug

New York Times Business •
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FDA granted expanded access for daraxonrasib, a three‑pill daily therapy from Revolution Medicines, to patients with previously treated metastatic pancreatic cancer. The move follows a late‑stage trial that showed median survival of over 13 months versus less than seven months on chemotherapy. With about 50,000 U.S. deaths annually, the approval could shift treatment options for a disease that yields a 3% five‑year survival rate.

Patient advocacy has been fierce; families and clinicians have petitioned for compassionate use, arguing that each month of delay adds another round of chemo. The FDA’s expanded‑access pathway, which it fulfills for more than 99% of requests, will now allow qualified doctors to obtain the drug free of charge from the company. Early access could alleviate pressure on limited trial slots that fill within days.

Investors are watching the rollout closely as Revolution anticipates a potential commercial launch pending fast‑track review by the Trump administration. If the drug secures approval later this year, revenue projections could surge, given the unmet need in a market worth billions. For now, the expanded‑access program offers a lifeline to patients while the company prepares for a full regulatory filing.