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# FDA Accepts Revolution Medicines' NDA for Pancreatic Cancer Therapy
- URL: https://www.fdaweb.com/fda-accepts-revolution-medicines-nda-for-pancreatic-cancer-therapy/
- Published: 2026-07-23T12:00:00.000Z
- Updated: 2026-09-14T13:43:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161508

FDA has accepted for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), the company announced Wednesday. The submission seeks approval of daraxonrasib for adults with metastatic PDAC who have previously received treatment. The drug is designed to inhibit activated RAS proteins, which drive the majority of pancreatic cancers, and could become one of the first broadly applicable RAS-targeted therapies for the disease if approved.

The NDA is supported by results from the global Phase 3 RASolute 302 trial, which compared daraxonrasib with investigator's choice of standard cytotoxic chemotherapy in patients with previously treated metastatic PDAC. According to the company, the study met all primary and key secondary endpoints, demonstrating statistically significant improvements in both overall survival and progression-free survival.

Revolution Medicines also reported that patients receiving daraxonrasib experienced delayed deterioration in cancer-related pain, overall health status and quality of life compared with chemotherapy, while the drug demonstrated a manageable safety profile. The Phase 3 data were presented at the 2026 American Society of Clinical Oncology Annual Meeting and published simultaneously in *The New England Journal of Medicine*.

"The FDA's acceptance of the daraxonrasib NDA is an important step in the regulatory review process and brings us closer to the possibility of offering patients a new targeted medicine for previously treated metastatic pancreatic cancer," said Mark Goldsmith, M.D., Ph.D., the company's chairman and chief executive officer. He said the Phase 3 results support the potential for daraxonrasib to become a new standard of care for the disease.

Daraxonrasib has received several FDA regulatory incentives, including Breakthrough Therapy Designation and Orphan Drug Designation for previously treated metastatic PDAC. It is also being reviewed through the Commissioner's National Priority Voucher pilot program, which is intended to accelerate review of therapies addressing significant public health priorities.

Pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer and remains one of the deadliest malignancies. Most patients are diagnosed with advanced or metastatic disease, and five-year survival for metastatic PDAC remains approximately 3%, underscoring the need for more effective therapies.

Earlier this year, FDA [authorized](https://www.fda.gov/news-events/press-announcements/fda-permits-expanded-access-investigational-pancreatic-cancer-drug?utm%5Fmedium=email&utm%5Fsource=govdelivery) an expanded access program for the therapy, allowing certain patients to receive the drug outside of clinical trials. The decision came just two days after FDA received the request on 4/28, underscoring what officials described as an effort to accelerate access to investigational therapies for serious and life-threatening conditions.

The therapy has been in the news lately after former Sen. **Ben Sasse** revealed he’s been taking it. Late last year, Sasse announced he was diagnosed with Stage 4 pancreatic cancer and given three to four months to live. Recently, he indicated that his tumors have shrunk by 76% since he started the treatment.