FDA approval · New moleculeFirst in class30-second read
Rasonquedaraxonrasib
Revolution Medicines · RAS inhibitor · Oncology
Bottom line for your patients
Adults with previously treated metastatic pancreatic adenocarcinoma have an oral targeted option that extended median overall survival over standard chemotherapy in its pivotal trial.
Drug brief
Drug IQ- Who it is for
- Adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
- What changes
- The pivotal trial compared Rasonque with standard chemotherapy in previously treated patients. FDA describes it as a first in class targeted therapy.
- The evidence
- In a randomized, open-label trial, Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy.Head-to-head randomized trialTrial not named in the FDA release · 500 participantsRandomized against an active treatment: the most direct evidence on how it compares with an existing option.
- Watch for
- The most common side effects are rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
- How it is given
- OralTablet taken once daily
- What the approval tells you
- New molecule. An active ingredient the FDA had not approved before.Priority review. The FDA aimed to decide in about 6 months instead of the standard 10. A faster clock, not a higher or lower evidence bar.Breakthrough therapy. Early clinical evidence suggested a substantial improvement over available therapy, so the FDA worked closely with the developer. Approval still required the full evidence.Orphan drug. Developed for a condition affecting fewer than 200,000 people in the US. Trials are often smaller.