The U.S. Food and Drug Administration approved Rasonque (daraxonrasib), a first-in-class RAS inhibitor developed by Revolution Medicines, on Wednesday for the treatment of adults with metastatic pancreatic adenocarcinoma.

The approval covers patients who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The drug is taken as a once-daily tablet and targets multiple forms of the RAS protein, a key driver in most cases of pancreatic adenocarcinoma.

In a randomized clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy. The drug also showed more than twofold improvement in progression-free survival.

The FDA granted the application Breakthrough Therapy and Orphan Drug designations along with Priority Review. Officials approved it 6.5 months ahead of the user fee deadline as part of the Commissioner’s National Priority Voucher program.

Pancreatic cancer remains one of the deadliest major cancers, with a five-year survival rate of about 13 percent according to the American Cancer Society. The disease is often diagnosed at advanced stages and has limited effective treatment options.

The approval provides a new option for patients with advanced disease who have exhausted other therapies. Some patients in earlier access programs have lived for years beyond typical expectations.

Revolution Medicines will market the drug under the brand name Rasonque. The company had offered expanded access to more than 2,000 patients following the key trial.