Revolution Medicines said on Wednesday the U.S. Food and Drug Administration approved its experimental drug Rasonque for metastatic pancreatic cancer in patients who have received prior treatment or are ineligible for combination chemotherapy.
The once-daily pill targets multiple forms of the RAS protein, a driver of tumor growth in many pancreatic cancers. The approval follows a large trial that showed the therapy doubled survival rates in patients with advanced disease, results announced in April. The FDA granted the clearance under its expedited review process, which compresses review timelines to roughly one to two months, compared with the standard 10 to 12 months.
Revolution Medicines priced Rasonque at $39,800 for a 30-day supply in the U.S., with financial assistance programs available. The company’s shares rose 166% over the prior year and traded relatively flat at $211.70 following the approval announcement.
RBC Capital Markets analysts estimate U.S. pancreatic cancer revenue of $28 million in the third quarter, supported by rapid approval and more than 2,000 patients already enrolled in the Expanded Access Program. Fourth-quarter sales are projected at $148 million, with long-term global annual sales potential of $11.5 billion. The American Cancer Society estimates about 67,350 new pancreatic cancer cases in the U.S. this year.
Mark Goldsmith, Revolution Medicines’ chief executive, said the approval validates over a decade of research focused on RAS-driven pancreatic cancer, one of oncology’s most challenging targets. Barbara Andes, an 88-year-old patient from Fullerton, California, began taking Rasonque in July after a year of chemotherapy. She described the drug as a “godsend” and said it would open treatment options for others suffering from the disease.
Clinicians also welcomed the approval. Rachna Shroff, chief of hematology and oncology at the University of Arizona Cancer Center, called it “just the tip of the iceberg” for targeting the RAS pathway in pancreatic cancer. She noted patients on Rasonque lived longer and maintained better quality of life than those on chemotherapy. Peter Hosein, associate director for clinical research at the Pancreatic Cancer Research Institute at Sylvester Comprehensive Cancer Center, described the breakthrough as a paradigm shift after decades of failed attempts to inhibit RAS.
