Your situation may even be simpler. Physicians can prescribe a medication approved for another use as “Off-label drug” use mwaninf that a drug that’s been approved by the FDA for one purpose is used for a different purpose that has not been approved. The provision in FDA regulations allows a doctor to prescribe the FDA approved drug for another purpose. The FDA regulates the testing and approval of drugs, but not how doctors use drugs to treat their patients.

The difference in my situation is PARPi’s we’re just being tested for the first time with pancreatic cancer and the trials were accepting both PDAC and PACC forms and somatic and germline BRCA mutations. Now there is history of it working in PDAC and limited data with PDAC because it is such a rare form. I was likely the first PACC patient it was tested on and was successful.