FDA approves Rasonque for metastatic pancreatic adenocarcinoma

The U.S. Food and Drug Administration said Tuesday that it approved Rasonque, also known as daraxonrasib, for adults with metastatic pancreatic adenocarcinoma, a late-stage form of pancreatic cancer.

The agency said the once-daily tablet is a first-in-class targeted therapy for adults who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. It said pancreatic adenocarcinoma is the most common type of pancreatic cancer and has long had limited treatment options.

Why it matters

The FDA said about 90% to 95% of the roughly 67,000 new pancreatic cancer cases diagnosed each year in the United States are pancreatic adenocarcinoma, citing the National Cancer Institute. The agency said the disease accounts for a disproportionately high share of cancer deaths because it is often found late and is aggressive.

In its announcement, the FDA said Rasonque targets multiple forms of the RAS protein, which it described as a key driver of tumor growth in most patients with pancreatic adenocarcinoma.

Trial results

The FDA said its decision was based on a randomized, open-label, multicenter clinical trial of 500 adults with previously treated metastatic pancreatic adenocarcinoma. Median overall survival was 13.2 months for Rasonque versus 6.7 months for standard chemotherapy, according to the agency.

The FDA said the most common side effects included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.

Background and review

The agency said the application received Breakthrough Therapy, Orphan Drug and Priority Review designations. It also said the review was handled under the Commissioner’s National Priority Voucher pilot program.

The FDA said that in May it issued a safe-to-proceed letter allowing an expanded access treatment protocol before approval.

What officials said

Acting FDA Commissioner Kyle Diamantas said the approval provides “a critical new option” for patients with an “extraordinarily difficult and historically hard-to-treat cancer,” according to the agency.

FDA oncology official Angelo de Claro said the drug showed “unprecedented results” in an area of high unmet need, the FDA said.

What happens next

The approval was granted to Revolution Medicines, Inc. The FDA said Rasonque is now available for the approved patient group.

Sources

• FDA press announcement: FDA approves first-in-class targeted therapy for metastatic pancreatic cancer

Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.