Study: patients nearly doubled survival with fewer severe side effects
The Food and Drug Administration on Wednesday approved daraxonrasib, a first-of-a-kind daily pill for the most common form of pancreatic cancer. FDA officials granted the drug expedited approval.
The approval offers U.S. patients a more effective treatment against one of the deadliest types of cancer. Daraxonrasib blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases, an approach that previously eluded drugmakers for decades.
Revolution Medicines will sell the daily pills under the brand name Rasonque.
The company-funded study behind the approval enrolled 500 patients whose metastatic, or spreading, cancer had quit responding to prior treatment. The trial randomly assigned participants to receive the experimental treatment or more chemotherapy.
Patients taking the drug nearly doubled their survival time, with fewer severe side effects, according to the study.
The clearance is the first for a medicine targeting the mutated protein behind the vast majority of pancreatic tumors, giving patients whose cancer has stopped responding to earlier treatment a new daily-pill option.