The U.S. Food and Drug Administration has approved a new cancer treatment pill, Rasonque, for patients with advanced pancreatic cancer. Manufactured by Revolution Medicines in California, the once-daily tablet targets multiple forms of a protein called RAS that drives tumor growth.
The FDA approved Rasonque more than six months ahead of its review deadline, citing the agency's duty to deliver more cures and meaningful treatments to patients as quickly as possible. Acting FDA Commissioner Kyle Diamantas praised the dedicated FDA scientists who reviewed the medication, saying their fast and thorough review made the approval possible.
The authorization is for adults with metastatic pancreatic cancer that has not responded to at least one prior treatment or cannot receive certain combination drug therapies. Pancreatic adenocarcinoma is one of the deadliest forms of oncology in the U.S., accounting for up to 95% of the roughly 67,000 annual pancreatic cancer cases identified by the National Cancer Institute.
In a randomized, open-label trial of 500 patients with pre-treated metastatic disease, patients taking Rasonque achieved a median overall survival of 13.2 months, nearly double the 6.7-month survival rate seen in the standard chemotherapy control group. Regulators accelerated the medication's path to market by granting it priority review, orphan drug status, and a breakthrough therapy designation.
Safety profiles show that the most frequent adverse events linked to Rasonque included rash, diarrhea, mouth sores, nausea, fatigue, vomiting, abdominal pain, fluid retention, reduced appetite, and bleeding. The FDA has authorized the use of Rasonque for adults with metastatic pancreatic cancer, providing a new treatment option for patients facing a historically hard-to-treat cancer.
NTC Report coverage is based on reporting from the original publisher.
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