August 26, 2026: the U.S. FDA approved daraxonrasib (RASONQUE) for metastatic pancreatic adenocarcinoma, the first RAS-targeted therapy approved for pancreatic cancer. All news →

FAQ

Mechanism, indications, efficacy, safety and access — answered

Basics

What is daraxonrasib?

Daraxonrasib (development code RMC-6236, U.S. brand name RASONQUE) is an oral RAS(ON) multi-selective inhibitor developed by Revolution Medicines. By forming a cyclophilin A–drug–RAS tri-complex, it blocks active mutant and wild-type RAS proteins from signalling downstream, thereby inhibiting tumor growth. It was approved by the U.S. FDA on August 26, 2026 for metastatic pancreatic adenocarcinoma.

How does it differ from KRAS G12C inhibitors such as sotorasib and adagrasib?

Sotorasib and adagrasib bind covalently to the cysteine of the KRAS G12C mutant and lock RAS in its inactive (OFF) state, so they only work in patients with a G12C mutation. Daraxonrasib directly inhibits RAS in its active (ON) state and does not depend on a specific mutant residue, so it is active against G12D, G12V, G12R, G12C, G13 and Q61 mutations as well as wild-type RAS — a far larger population, and particularly relevant in pancreatic cancer, where G12D, G12V and G12R predominate.

Indications

What is daraxonrasib currently approved for?

The FDA-approved indication is adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy. The indication is not restricted by RAS mutation status. Other indications (first-line pancreatic cancer, adjuvant therapy, non-small cell lung cancer and others) remain in Phase 3 clinical trials.

Is KRAS testing required before treatment?

The FDA-approved indication does not require a specific RAS mutation status; in RASolute 302 both the RAS G12-mutant population and the overall population benefited. That said, more than 90% of pancreatic adenocarcinomas carry a KRAS mutation, and molecular testing helps characterise the tumor and guide subsequent treatment choices. Follow your physician's advice and the current prescribing information.

Clinical data

How effective is daraxonrasib?

In the Phase 3 RASolute 302 trial, compared with standard chemotherapy, daraxonrasib extended median overall survival in previously treated metastatic pancreatic cancer from 6.7 to 13.2 months (a 60% reduction in the risk of death), extended median progression-free survival from 3.6 to 7.2 months, increased the objective response rate from 11% to 30%, and significantly delayed deterioration in pain and quality of life.

Does daraxonrasib work in non-small cell lung cancer?

It is not yet approved for lung cancer. Phase 1/2 data published in NEJM in September 2026 showed an objective response rate of 42%, median progression-free survival of 8.3 months and median overall survival of 16 months in previously treated RAS-mutant NSCLC. The Phase 3 RASolve 301 trial (vs docetaxel) is ongoing.

Safety

What are the common side effects, and how serious are they?

The most common adverse reactions are rash, stomatitis, diarrhoea, nausea, vomiting and fatigue, mostly mild to moderate (grade 1–2) and manageable with preventive skin care, oral care, antidiarrhoeals and antiemetics, and dose reduction where necessary. In the Phase 3 trial, grade ≥3 treatment-related adverse events (43.6%) and discontinuations due to adverse events (1.2%) were both lower with daraxonrasib than with chemotherapy. The label also warns of gastrointestinal perforation, interstitial lung disease/pneumonitis and embryo-fetal toxicity; treatment should be monitored by a physician.

Dosing

How is it taken, and at what dose?

The recommended dose is 300 mg orally once daily, continued until disease progression or unacceptable toxicity. For details on food, missed doses and interactions with other medicines, consult the prescribing information and your physician or pharmacist.

Access

Is daraxonrasib available in China?

As of this site's last update, daraxonrasib had not been approved in mainland China. Patients can follow announcements from the National Medical Products Administration (NMPA) or search ClinicalTrials.gov and the Chinese drug trial registry for recruiting studies. This site does not sell or source medicines.

About this site

How reliable is this site, and how often is it updated?

Content is compiled from the FDA approval notice, Revolution Medicines press releases, peer-reviewed journals such as NEJM, and public presentations at ASCO/ESMO and other congresses; the date of last review appears at the bottom of every page. We revise content as public information evolves, but this site is not medical advice — consult a specialist for any treatment decision.

Content on this site is provided for informational purposes for healthcare professionals and the public. It does not constitute medical advice, diagnosis or treatment. Always follow your physician's guidance and the official prescribing information. Read the full disclaimer