FDA Approves Revolution Medicines' Targeted Pancreatic Cancer Drug Rasonque

The US Food and Drug Administration has approved Revolution Medicines' Rasonque, a targeted therapy for adults battling metastatic pancreatic cancer. This once-daily pill, also known as daraxonrasib, aims to block the RAS protein, a common culprit in driving tumor growth.

The approval marks a significant step forward for pancreatic cancer treatment, a disease with a notoriously low five-year survival rate of approximately 13%. Rasonque's approval was based on a study involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. The study demonstrated that the drug improved overall survival to 13.2 months, a notable increase from the 6.7 months seen with standard chemotherapy.

Rasonque is a first-in-class cancer drug that received an accelerated review through the FDA Commissioner's National Priority Voucher program. This program fast-tracks therapies addressing critical US health priorities and unmet medical needs. The drug had previously been made available to patients with serious or life-threatening conditions through an early access program.

Common side effects reported for Rasonque include rash, diarrhea, mouth inflammation, nausea, tiredness, vomiting, abdominal pain, swelling, reduced appetite, and bleeding. Revolution Medicines has not yet commented on the drug's pricing and availability.