Dr Reiss Binder on the FDA Approval of Daraxonrasib for Metastatic PDAC

“The patients who received daraxonrasib lived twice as long as those who received chemotherapy. That is something we’ve never seen before in a pancreatic cancer study.”

Kim A. Reiss Binder, MD, the assistant program director of the Hematology/Oncology Fellowship Program and an associate professor of medicine (hematology-oncology) at the Hospital of the University of Pennsylvania, discussed the significance of the FDA approval of daraxonrasib (Rasonque) for metastatic pancreatic ductal adenocarcinoma (PDAC) and what the ability to target RAS broadly could mean for pancreatic cancer and other RAS-driven cancers.

The approval is unquestionably one of the biggest breakthroughs the pancreatic cancer field has seen, Reiss Binder said. She was careful to note that it does not mark the end of research or progress, but rather, a beginning.

On August 26, 2026, the FDA approved daraxonrasib, an oral RAS(ON) multiselective inhibitor, for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multi-agent systemic therapy. This regulatory decision was based on findings from the phase 3 RASolute 302 trial (NCT06625320).

RASolute 302 randomly assigned patients with metastatic PDAC who had received at least 1 prior line of chemotherapy to receive second-line chemotherapy or daraxonrasib. In the RAS G12–mutated population, the median OS was 13.2 months (95% CI, 10.0-not estimable) with daraxonrasib vs 6.6 months (95% CI, 5.4-8.2) with chemotherapy (HR, 0.40; 95% CI, 0.30-0.54; P = 5.9×10⁻¹⁰), with 12-month OS rates of 53.3% vs 18.7%, respectively. The median progression-free survival values by blinded independent central review in this population were 7.3 months (95% CI, 6.3-8.1) vs 3.5 months (95% CI, 2.9-3.8), respectively (HR, 0.45; 95% CI, 0.34-0.59; P = 3.2×10⁻⁹), and the confirmed objective response rates were 33.2% vs 11.8%, respectively (P < .0001).

With daraxonrasib now approved, Reiss Binder contended that a new era for pancreatic cancer has arrived, adding that this also offers hope for other commonly RAS-driven cancers, such as non–small cell lung cancer and colorectal cancer. Whereas KRAS G12C inhibitors, such as sotorasib (Lumakras) and adagrasib (Krazati), recently entered the treatment paradigm, the ability to now target RAS mutations across the board opens further future possibilities, according to Reiss Binder.