FDA Approves Revolution Medicines Targeted Pancreatic Cancer Drug

The U.S. Food and Drug Administration on Wednesday approved daraxonrasib, a groundbreaking once-daily pill developed by Revolution Medicines for adult patients suffering from advanced or metastatic pancreatic cancer.

Marketed under the brand name Rasonque, the targeted therapy blocks multiple variants of the RAS protein that drive tumor growth. It is indicated for patients who have previously received treatment or cannot tolerate combination chemotherapy.

The regulator processed the approval under its National Priority Voucher program, accelerating the review process to just one to two months. The FDA also granted early access prior to authorization for patients facing life-threatening conditions.

Clinical trials involving 500 adults with previously treated metastatic pancreatic adenocarcinoma demonstrated that Rasonque nearly doubled median overall survival to 13.2 months, compared to 6.7 months for standard chemotherapy.

Pancreatic cancer remains one of the most lethal malignancies, carrying a five-year survival rate of approximately 13 percent, according to the American Cancer Society.

Addressing the clinical significance of the approval, medical professionals underscored its impact on patient care.

"It will be transformative in the way we treat pancreas cancer. It’s the biggest development we’ve had in pancreas cancer in decades," said Andrew Ko, a medical oncologist specializing in gastrointestinal cancers at the University of California, San Francisco.

Ko emphasized the immediate value of the newly authorized therapeutic option for the oncology community.

"I’m so thankful for this as an advance for our patients," said Andrew Ko, a medical oncologist specializing in gastrointestinal cancers at the University of California, San Francisco.

Common side effects associated with the daily pill include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite, and bleeding.