The Food and Drug Administration has approved Rasonque, a new daily pill for adults treating advanced pancreatic cancer, the United States regulatory agency announced.
In a statement, the agency described the medication as a fundamental option for patients facing an extraordinarily difficult and historically hard to treat disease.
The therapy is intended for adult patients who have already undergone at least one prior treatment, such as chemotherapy, for metastatic pancreatic cancer. In clinical trials, the oral medication more than doubled patient survival rates, extending average survival from 6.7 months to 13.2 months.
Unlike standard chemotherapy, which acts broadly to slow cell growth, Rasonque targets specific genetic mutations in the KRAS gene. When active, the KRAS protein stimulates cell growth, but mutations keep the protein permanently active like a switch stuck in the on position. The pill binds to the protein to turn it off.
European approval and international rollout
Following approval in the United States, the European Medicines Agency is expected to take similar action. European regulators have opened a fast track approval process for the drug due to its potential impact on treating pancreatic cancer.
European approval could occur by late 2026 or early 2027. Before the medication can be sold in Portugal, national drug authority Infarmed must also clear its commercialization, a process that typically takes several months.
Pancreatic cancer remains one of the deadliest forms of cancer. In Portugal, more than 1,000 new cases are diagnosed every year. The country records one of the lowest survival rates for the disease at 15.9 percent, according to figures released in May by the National Oncology Registry.
Treatment costs and medical access
In the United States, a single month of treatment with Rasonque costs 39,800 dollars, which equals approximately 34,298 euros. It is not yet known when the drug will arrive in Portugal or become accessible to European patients.
