Washington—The U.S. Food and Drug Administration (FDA) on Wednesday approved a new treatment for advanced pancreatic cancer, in what specialists consider one of the most significant advances in recent decades against one of the deadliest cancers.
The drug, called daraxonrasib and marketed under the name
Rasonque, is a daily tablet developed by Revolution Medicines. It works by
blocking different forms of the RAS protein, which is linked to the growth of
pancreatic tumors.
The approval is for adults with metastatic pancreatic
adenocarcinoma who have already received at least one line of systemic therapy
or who cannot receive certain combination chemotherapy regimens.
The most noteworthy result comes from a clinical trial
conducted with 500 patients. Patients who received daraxonrasib achieved a
median survival of 13.2 months, compared to 6.7 months for those who received
standard chemotherapy, nearly doubling the survival time observed in the study.
This advance is especially significant because pancreatic
cancer is often detected only after it has spread to other organs, and for decades
it has been particularly difficult to develop drugs capable of directly
targeting the molecular alterations that drive its growth.
Rasonque represents precisely a new strategy: targeting RAS,
a protein that plays a fundamental role in the growth of numerous pancreatic
tumors. The FDA described the authorization as a new therapeutic option for
patients facing a historically difficult-to-treat disease.
However, the drug is not a cure. Its approval is for
patients with advanced disease and is based on its ability to prolong survival.
Observed side effects include skin rashes, gastrointestinal problems, mouth
sores, and other treatment-related symptoms.
The approval process was also expedited: the FDA authorized
the drug months before the expected deadline for completing its review. The
agency stated that the decision aims to make treatments for serious diseases
with few therapeutic alternatives more readily available to patients.
Pancreatic cancer remains one of the tumors with the lowest
survival rates among the major cancer types. In the United States,
approximately 67,000 new cases are expected in 2026, and the overall five-year
survival rate is only about 13 percent.
The arrival of Rasonque now opens a new chapter in the
treatment of this disease and could spur the development of similar drugs
targeting the molecular alterations that for years were considered virtually
impossible to treat.