Revolution Medicines NDA for Darxonerasib Accepted by FDA Targeting Metastatic Pancreatic Cancer

(RTTNews) – Revolution Medicines, Inc. (RVMD) announced that the U.S. FDA has accepted for review its New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for patients with metastatic pancreatic ductal adenocarcinoma.

Metastatic pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive cancers, often linked to mutations in the RAS gene family. Daraxonrasib is designed to inhibit RAS, the primary driver of pancreatic cancer, and the application is supported by results from the Phase 3 RASolute 302 trial.

This global, randomized study compared Darxonerasib to standard chemotherapy in previously treated metastatic PDAC patients, with or without identified RAS mutations. The trial met all primary and key secondary endpoints, showing unprecedented improvements in overall survival and progression-free survival.

Patients treated with Darxonerasib also reported delayed deterioration in cancer-related pain, overall health status and quality of life, compared to chemotherapy. The safety profile was considered manageable. Results were presented at the ASCO 2026 meeting and published in the New England Journal of Medicine.

The FDA has previously granted Darxonrasib Breakthrough Therapy Designation and Orphan Drug Designation, and the NDA has been selected for the FDA Commissioner’s National Priority Voucher pilot program, which accelerates review of medicines addressing critical health priorities.

CEO Mark A. Goldsmith stated that the acceptance marks an important step toward potentially offering patients a new targeted therapy and advancing a new class of RAS-focused medicines for pancreatic cancer.

RVMD has traded between $34.00 and $193.82 over the past year. The stock closed Wednesday’s trading at $183.03, down 0.14%. During the after-hours trading session, the stock is at $186.45, up 1.87%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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