FDA Approves Rasonque for Pancreatic Cancer

FDA Approves New Pancreatic Cancer Drug after Trial Nearly Doubles Survival

Life Sciences and Bio Pharma

U.S. FDA has approved Rasonque, a targeted treatment for advanced pancreatic cancer, after a Phase 3 trial showed a substantial survival benefit over standard chemotherapy.

FDA has approved Rasonque for certain adults with metastatic pancreatic cancer
The Phase 3 trial involved 500 previously treated patients
Median survival reached 13.2 months versus 6.7 months with chemotherapy
Rasonque reduced the risk of death by 60% in the trial
The U.S. list price is $39,800 for a 30-day supply

The U.S. Food and Drug Administration (FDA) has recently approved Rasonque (daraxonrasib), an oral treatment for adults with advanced pancreatic cancer who have already had at least one treatment or cannot handle combination chemotherapy.

Rasonque is FDA-approved based on a phase 3 trial conducted among 500 patients suffering from metastatic pancreatic cancer that has already been treated. In the trial, patients on Rasonque therapy had a median overall survival of 13.2 months, whereas the control group treated with standard chemotherapy had a median survival of 6.7 months. Moreover, Rasonque therapy decreased mortality risk by 60% in the trial.

This targeted therapy works on RAS proteins, which help tumors to grow. This drug, developed by Revolution Medicines, is a novel class of broad RAS-targeted therapies. This type of cancer makes up around 90-95% of the total number of cases of pancreatic cancer diagnosed in the United States, and it poses problems when treating it because it is usually diagnosed in its late stage.

Rasonque was granted FDA approval through priority review six months and 15 days before its expiration date. This therapy has been designated as a Breakthrough Therapy and an Orphan Drug. Revolution Medicines announced that Rasonque is now available for prescription use in the United States. The cost for a month’s treatment has been set to $39,800. According to the FDA, the possible adverse effects are rash, diarrhea, mouth irritation, nausea, fatigue, vomiting, stomach pain, edema, loss of appetite, and bleeding.

The medication does not offer any cure for pancreatic cancer. However, the drug's approval provides another treatment option for patients who have already received other treatments for metastatic cancer and has resulted in more drugs that target specific biological processes that help cancer cells grow. Business Honor believes Rasonque is a promising advance in pancreatic cancer treatment, but its impact will depend on long-term results, safety and patient access.