Compassionate use drug spotlight: Daraxonrasib

Daraxonrasib is a new oral drug for pancreatic cancer that is not yet approved by the Food and Drug Administration (FDA). However, qualifying patients may be able to access it through a compassionate use program offered by the manufacturer, Revolution Medicines.

Who May Qualify

Patients with RAS-mutant Stage IV pancreatic cancer may qualify for the Daraxonrasib compassionate use program if they meet all of the following criteria:

• Have already tried standard treatments
• Have no other viable treatment options
• Are not eligible for an available clinical trial

Steps for the Ordering Physician’s Office

1. Contact Revolution Medicines to request the drug and complete their required certification process.
2. Complete FDA Form 3926, the standard form for individual patient expanded access. The form is available at fda.gov (search “Form 3926”). Free assistance is available through FDA Project Facilitate at 240-402-0004 or [email protected].
3. Obtain IRB approval. Hospital-based practices should work through their institution’s Institutional Review Board (IRB). For guidance on locating a registered IRB, independent or private practices can visit www.reaganudall.org, select the Expanded Access eRequest tab and then select the Resources.
4. Await shipment. Once the drug manufacturer, FDA and IRB have each granted approval, Daraxonrasib will be shipped directly to the practice site.

Note: EviCore by Evernorth^® does not manage the compassionate use process. The steps above are provided for informational purposes to help provider offices navigate the process independently.