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Daraxonrasib has received breakthrough therapy designation from the FDA for KRAS G12+, previously treated, metastatic pancreatic ductal adenocarcinoma.
Daraxonrasib has received breakthrough therapy designation from the FDA for KRAS G12+, previously treated, metastatic PDAC: © stock.adobe.com.
The investigative agent daraxonrasib (RMC-6236) has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12 mutations, according to a news release from Revolution Medicines, Inc.
The breakthrough therapy designation aims to accelerate the development and review of new therapeutic agents for individuals with serious conditions that have significant unmet medical needs. To qualify, the investigative therapy — in this case, daraxonrasib — must show preliminary clinical evidence indicating a substantial improvement for patients compared with existing treatments.
This regulatory decision is based on early clinical evidence with daraxonrasib in the phase 1 RMC-6236-001 study evaluating daraxonrasib in patients with PDAC. Notably, the registrational, phase 3 RASolute 302 study is expanding the evaluation of daraxonrasib and is examining the use of daraxonrasib in patients with previously treated, metastatic PDAC. This trial is expected to substantially complete enrollment this year.
“This breakthrough therapy designation underscores the enormous need for new treatments for patients with pancreatic cancer and highlights the potentially important role the investigational drug, daraxonrasib, may have in helping patients living with this disease,” Dr. Mark A. Goldsmith, PhD, chief executive officer and chairman of Revolution Medicines, stated in the news release. “We look forward to substantially completing enrollment of the RASolute 302 study this year to enable an expected readout in 2026 and, should the results support it, working closely with the FDA and other regulatory agencies around the world to bring daraxonrasib to patients as quickly as possible.”
The oral, direct RAS(ON) multi-selective inhibitor, daraxonrasib, has the potential to treat various cancers driven by oncogenic RAS mutations. This is done by stopping RAS signaling, thereby blocking common oncogenic RAS mutations, which are the key drivers of several major cancers, including PDAC, non-small cell lung cancer and colorectal cancer. Notably, more than 90% of individuals with PDAC have tumors driven by RAS mutations; approximately 85% harbor a KRAS G12 mutation.
Progression-free survival (PFS): The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Overall survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.
To combat the unmet needs within this patient population, the global RASolute 302 trial is underway, seeking to continue to the evaluation of daraxonrasib in previously treated metastatic PDAC. The trial focuses on patients with PDAC containing RAS mutations like RAS G12X, while an expanded cohort is evaluating patients with RAS G13X and RAS Q61X. The primary end points of the upcoming trial are progression-free survival and overall survival in the main patient population, while secondary end points include progression-free survival and overall survival in the expanded population.
Pancreatic cancer is among the most lethal cancers, as an estimated 60,000 people were diagnosed with pancreatic cancer and approximately 50,000 died from it in 2024 in the United States alone. The disease is marked by a tendency for late diagnosis, resistance to conventional chemotherapy, and a high mortality rate.
PDAC is a type of pancreatic cancer and is the most common form of the disease. PDAC and its variants represent approximately 92% of all pancreatic cancer cases. Due to the absence of early symptoms and effective screening methods, approximately 80% of PDAC cases are diagnosed at an advanced or metastatic stage. Metastatic PDAC continues to be a leading cause of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.
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