Pancreatic cancer: The US Food and Drug Administration has cleared the way for limited early access to an experimental drug for pancreatic cancer, offering a potential lifeline to some patients while formal approval is still pending.
The drug, daraxonrasib, developed by Revolution Medicines, is still under review. But recent late-stage trial results have drawn attention for showing improved survival in patients with advanced pancreatic cancer, especially those whose disease has already spread.
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According to the regulator, the company’s request for expanded access was reviewed and approved within a short window, allowing certain patients who have already undergone treatment to receive the drug outside of clinical trials. These programmes are usually considered when existing treatment options are limited and the disease is serious.
Pancreatic cancer continues to be one of the most aggressive and difficult-to-treat cancers. Survival rates remain low, particularly in cases where the cancer has spread to other organs. For many patients, treatment focuses more on extending life and managing symptoms than achieving a cure.
In the clinical study shared last month, patients taking daraxonrasib lived a median of 13.2 months. By comparison, those on standard chemotherapy had a median survival of 6.7 months. While the difference is significant, experts caution that the results need to be followed over time to understand the long-term impact.
The company is now expected to pursue a faster review pathway, given the urgency around treatment options for pancreatic cancer.
At the same time, researchers say the progress, while promising, is still early. There are concerns that the cancer could eventually become resistant to treatment, and future studies will likely focus on combining this drug with other therapies to improve outcomes.