The FDA has approved Revolution Medicines' daraxonrasib (brand name: Rasonque) for metastatic pancreatic cancer — a disease with a brutal 13% five-year survival rate. The once-daily pill, which targets RAS mutations driving tumor growth in ~90% of pancreatic cancers, doubled survival compared to chemotherapy in a 500-person trial. It sailed through the FDA's new expedited review process, going from application to approval in as little as one to two months.
The FDA has officially approved daraxonrasib (Rasonque), Revolution Medicines' once-daily pill for metastatic pancreatic cancer in patients who've already received prior treatment or can't tolerate combination chemotherapy. The drug is the first in a new class called RAS(ON) inhibitors, targeting RAS mutations found in over 90% of pancreatic cancers — and it's rewriting what's possible for one of oncology's toughest diseases.
In a landmark 500-person trial, daraxonrasib reduced the overall risk of death by 60% compared to chemotherapy, extending median survival to 13.2 months versus 6.7 months. Tumor shrinkage or disappearance was seen in ~32% of patients on the drug, compared to ~11% on chemo. Side effects — most notably rash (86% of patients) — were largely manageable, and severe side effects were actually less common than with chemotherapy (43.6% vs. 57.5%).
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Why it matters: Pancreatic cancer has long been a near-death sentence, with a 5-year survival rate of just 13%. Daraxonrasib's approval — fast-tracked through the FDA's new expedited review process — marks a genuine paradigm shift, offering patients a tolerable oral option that dramatically outperforms the current standard of care.
