Revolution Medicines, Inc., a global commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved RASONQUE (daraxonrasib) once-daily oral tablets, for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE represents the first targeted cancer medicine to be approved from a groundbreaking new class of RAS(ON) multi-selective and mutant-selective inhibitors.

Pancreatic cancer is among the most challenging malignancies, frequently presenting with a late diagnosis, aggressive biology and limited responsiveness to conventional treatments. RAS, a key growth control switch in human cells, is the main cause of pancreatic cancer, which is characterized by excessive RAS signaling. The approval of RASONQUE is for adults with metastatic PDAC with or without an identified RAS tumor mutation and does not require use of a companion diagnostic test.

“The FDA approval of RASONQUE is a monumental step forward for patients with pancreatic cancer and for the oncology field. For the first time, patients have an approved targeted medicine designed to directly inhibit the main cause of pancreatic cancer, RAS, which has been one of the most intractable disease targets since its discovery decades ago. The unprecedented results of the global Phase 3 trial position RASONQUE to become the new standard of care for patients with metastatic pancreatic cancer under an approved label that supports real-world clinical decision-making. This approval further validates our bold RAS(ON) inhibitor strategy that includes multi-selective and mutant-selective approaches targeting a major driver of pancreatic cancer and multiple other cancers. We continue to engage with global regulatory authorities with the goal of expanding and accelerating the reach of RASONQUE,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

“Today’s landmark approval is the most significant advance we have seen in the fight against pancreatic cancer, a devastating disease. I believe this drug will transform how pancreatic cancer is treated, giving people the opportunity for more time with loved ones, the possibility of a better quality of life and optimism that continued research may lead to even greater advances,” said Anna Berkenblit, M.D., chief scientific and medical officer of the Pancreatic Cancer Action Network (PanCAN). “In addition, an oral pill can offer a less burdensome treatment experience than standard intravenous chemotherapy. PanCAN will continue to empower patients and caregivers with the resources and knowledge they need to advocate for the care they deserve now that RASONQUE is available for doctors to prescribe.”

“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. 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. This approval gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients and provides a critically needed new approach to treating patients with metastatic pancreatic cancer,” added Brian M. Wolpin, M.D., M.P.H., director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and principal investigator for the RASolute 302 trial.