The Food and Drug Administration approved a life-extending treatment for advanced pancreatic cancer on Wednesday, the first drug designed to block a genetic driver of the disease. A genetic driver, in plain terms, is a mutation that acts like a standing order inside cancer cells, telling them to multiply without stopping. Revolution Medicines, a biotech company, will market the treatment under the brand name Rasonque; the drug's scientific name is daraxonrasib.
Rasonque's approval rested on a clinical trial that produced results earlier this year. The trial enrolled patients who had already gone through one round of therapy that did not work, a setting called second-line. Those patients, on Rasonque, reached a median overall survival of 13.2 months. Median overall survival is the point in a study at which half the patients enrolled are still alive. Patients who received standard chemotherapy in the same second-line setting reached 6.7 months.
That gap is large by the standards of a cancer described as aggressive and highly lethal.
Andrew Ko, a medical oncologist specializing in gastrointestinal cancers at the University of California, San Francisco, said the drug will change the way pancreatic cancer is treated and called it the biggest development in the disease in decades. He said he was thankful for what it means for patients.
Daraxonrasib is the first drug cleared by the FDA to target the genetic cause of this cancer rather than attacking tumor cells without that specificity.