On October 27, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer.
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"We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer, a devastating disease with limited therapeutic options and representing a large unmet medical need," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "RAS driver mutations are present in nearly all pancreatic cancer cases, underscoring the urgent need for innovative therapies that target this critical driver of disease progression."
Daraxonrasib is being studied in a global Phase 3 clinical trial, RASolute 302, in patients with second line metastatic pancreatic ductal adenocarcinoma (PDAC). The company has also announced plans to initiate two additional Phase 3 clinical trials in pancreatic cancer: a trial for first line treatment in patients with metastatic PDAC and a trial for adjuvant treatment in patients with resectable PDAC.
Orphan Drug Designation is awarded by the FDA on behalf of selected investigational drugs to encourage the development of therapies for rare diseases, which are defined as conditions affecting fewer than 200,000 individuals in the United States. This designation provides sponsors with several incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity following approval.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.
Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations2. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%3.
About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
(Press release, Revolution Medicines, OCT 27, 2025, View Source [SID1234657037])