FDA Approves Revolution Medicines Pancreatic Cancer Drug

The U.S. Food and Drug Administration has approved Revolution Medicines’ targeted cancer drug Rasonque for certain adults with metastatic pancreatic cancer, providing a new treatment option for a disease with limited effective therapies.

Rasonque, also known as daraxonrasib, is a once-daily oral medication designed to block multiple forms of the RAS protein, which plays a key role in driving tumor growth in many pancreatic cancers.

The drug is approved for adults with metastatic pancreatic cancer who have previously received treatment or are unable to receive combination chemotherapy.

Rasonque was included in the FDA Commissioner’s National Priority Voucher program, an initiative intended to shorten review timelines for therapies addressing major U.S. health priorities and significant unmet medical needs. Under the program, reviews that typically take 10 to 12 months can potentially be completed in as little as one to two months.

The approval is particularly significant because pancreatic cancer remains one of the deadliest major cancers. According to the American Cancer Society, the five-year survival rate is approximately 13%.

The FDA’s decision was supported by results from a study involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, the most common form of pancreatic cancer.

Patients treated with Rasonque had an overall survival of 13.2 months, compared with 6.7 months among patients who received standard chemotherapy.

Before receiving full regulatory approval, Rasonque had also been made available through an FDA early-access program that allows some patients with serious or life-threatening illnesses to receive experimental therapies outside clinical trials.

The most commonly reported side effects included rash, diarrhea, inflammation of the mouth, nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite, and bleeding.

Revolution Medicines had not immediately provided details about the drug’s pricing or availability.