Who is eligible for daraxonrasib?

The approved indication

Daraxonrasib is an oral multi-selective RAS(ON) inhibitor. The FDA approval covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy. If you do not meet that description, you are outside the label.

Approval rested on RASolute 302, a randomized phase 3 trial of 500 patients comparing daraxonrasib with physician's choice chemotherapy in the second-line setting. Median overall survival was 13.2 months versus 6.7 months, and median progression-free survival 7.2 months versus 3.6 months, with a response rate of 30% versus 11%.

What to confirm in your own records

Eligibility questions usually come down to documentation rather than biology.

• Histology confirmed as pancreatic adenocarcinoma, and documented metastatic disease
• At least one prior line of systemic therapy, or a documented reason you cannot receive multiagent chemotherapy
• RAS status from tissue or liquid biopsy, since trial options in other settings are RAS-defined
• Organ function, performance status, and any conditions that affect tolerability

Other cancers and trial access

RAS mutations are common in colorectal and lung cancer, and development of RAS(ON) inhibitors extends well beyond pancreatic disease. Access in those settings is through trials, which means eligibility turns on specific mutation, prior therapy history, measurable disease, and washout requirements.

Screening those criteria against a full record, one trial at a time, is the Clinical Trial Search add-on inside Active Case Management. A Molecular Strategy engagement gives the landscape view: what is open, what is coming, and which options your biology actually supports.

Safety worth knowing about

Labeled warnings include dermatologic and soft tissue toxicity, stomatitis and other oral problems, and diarrhea. Prophylactic and supportive medications are given to reduce skin reactions, and dosing is modified or held based on severity. Tolerability management is a real part of staying on this drug.

Related questions

Is daraxonrasib approved for colorectal or lung cancer?

No. The current FDA approval is limited to metastatic pancreatic adenocarcinoma in the setting described above. Other tumor types are being studied in trials.

Do I need a specific KRAS mutation to receive it?

The approved indication is not restricted to a single variant, and the trial showed benefit in both the RAS G12 population and the overall population. Trials in other diseases often are mutation-specific.

How do I find out whether I qualify?

The answer sits in your pathology, treatment history, and molecular reports read together. If nobody has done that in one pass, a Molecular Strategy review will.