FDA approves targeted drug for pancreatic cancer
The U.S. Food and Drug Administration has approved Revolution Medicines’ targeted drug for adults with metastatic pancreatic cancer who have received prior treatment or cannot undergo combination chemotherapy, reports BritPanorama.
The drug, branded as Rasonque and also known as daraxonrasib, is a once-daily pill designed to block multiple forms of the RAS protein, a key driver of tumor growth in many pancreatic cancers.
Rasonque, a first-in-class cancer medication, was included in the FDA’s Commissioner’s National Priority Voucher program, which accelerates review timelines from 10 to 12 months down to as little as one to two months for therapies addressing significant health priorities and unmet medical needs.
The approval represents a notable advancement in a field marked by a five-year survival rate of approximately 13%, one of the lowest among major cancers, according to the American Cancer Society. This decision was based on a study of 500 adults with previously treated metastatic pancreatic adenocarcinoma, showing that the drug improved overall survival to 13.2 months compared to 6.7 months for standard chemotherapy.
The FDA had previously granted early access to the drug, allowing patients with serious or life-threatening conditions to receive experimental treatments outside clinical trials before regulatory authorization. The most common side effects reported included rash, diarrhea, mouth inflammation, nausea, tiredness, vomiting, abdominal pain, swelling, reduced appetite, and bleeding.
Revolution Medicines did not immediately respond to inquiries concerning the pricing and availability of Rasonque.
As the landscape of pancreatic cancer treatment evolves, the implications of Rasonque’s approval could reshape therapeutic options for patients facing this challenging disease.
