REDWOOD CITY, California: The U.S. Food and Drug Administration has approved Revolution Medicines' targeted drug Rasonque for adults with metastatic pancreatic cancer who have received prior treatment or cannot receive combination chemotherapy.

The once-daily pill, also known as daraxonrasib, is designed to block several forms of the RAS protein, which helps drive tumor growth in many pancreatic cancers.

Rasonque, a first-in-class cancer drug, was included in the FDA Commissioner's National Priority Voucher program, which is designed to accelerate reviews from the usual 10 to 12 months to as little as one to two months for therapies addressing major U.S. health priorities and substantial unmet medical needs.

The FDA approval marks a significant advance in a disease area with limited effective treatment options and a five-year survival rate of about 13 percent, one of the lowest among major cancers, according to the American Cancer Society.

The approval was based on a study involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, the most common type of pancreatic cancer.

The drug improved overall survival to 13.2 months, compared with 6.7 months for patients receiving standard chemotherapy.

The FDA previously granted early access to Rasonque under a program that allows patients with serious or life-threatening conditions to receive experimental treatments outside clinical trials before regulatory authorization.

The drug's most common side effects included rash, diarrhea, mouth inflammation, nausea, tiredness, vomiting, abdominal pain, swelling, reduced appetite, and bleeding.

Revolution Medicines did not immediately respond to a request for comment on the drug's pricing and availability.