US authorisation illustrates how targeted therapies can reshape outcomes in cancer patients even in the most aggressive forms of the disease.
The US Food and Drug Administration (FDA) has approved Revolution Medicines’ Rasonque (daraxonrasib) as the first broad RAS-targeted for metastatic pancreatic ductal cancer.
Dr Mark Goldsmith, Revolution’s CEO, highlighted that this is the first time these patients can access a treatment that directly inhibits RAS. FDA’s decision is based on data from a large Phase III trial that showed the oral RAS inhibitor nearly doubled median survival.
Dr Brian Wolpin, principal investigator for the RASolute 302 trial noted: “For decades, despite RAS being the main driver and potential drug target for pancreatic cancer, physicians have largely relied on intravenous cytotoxic chemotherapy to treat this aggressive disease.”
Rasonque is a multi-selective, noncovalent, tri-complex inhibitor, designed to target cancers driven by a broad range of common RAS genotypes. This includes pancreatic cancer, non-small cell lung cancer (NSCLC) and colorectal cancer.
Acting FDA Commissioner Kyle Diamantas, said that approval of Rasonque provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.” Late diagnosis is common, making treatment challenging.
Dr Angelo de Claro, Director of the FDA’s Oncology Center of Excellence, explained that in the RASolute 302 trial, Rasonque showed “unprecedented results in an area of high unmet need”. Specifically, the RAS inhibitor reduced the risk of death by 60 percent, improving median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy.
daraxonrasib is well positioned to become a new standard of care for adults with metastatic pancreatic cancer who have already received at least one systemic therapy or who are not candidates for multiagent systemic therapy”
Dr Anna Berkenblit, Chief Scientific and Medical Officer of the Pancreatic Cancer Action Network (PanCAN) said:
Dr Anna Berkenblit, Chief Scientific and Medical Officer of the Pancreatic Cancer Action Network (PanCAN) said: “I believe daraxonrasib is well positioned to become a new standard of care for adults with metastatic pancreatic cancer who have already received at least one systemic therapy or who are not candidates for multiagent systemic therapy.”
No comments yet