Revolution Medicines Gets FDA Safe to Proceed Letter for Pancreatic Cancer
Revolution Medicines said the FDA issued a safe to proceed letter on May 1 for daraxonrasib in pancreatic cancer, allowing the company to start an expanded access treatment protocol for patients with previously treated metastatic pancreatic ductal adenocarcinoma. The company said requests for access must come from a licensed treating physician.
Daraxonrasib and FDA access
The protocol is designed to offer treatment access in a monitored and controlled setting consistent with FDA regulations governing investigational medicines. Daraxonrasib is an investigational RAS(ON) inhibitor, and Revolution Medicines said it is moving as quickly as possible to ensure safe and equitable access for eligible patients in the United States.
Licensed physicians must initiate requests
Revolution Medicines said it cannot accept direct requests from caregivers or patients under FDA regulations governing expanded access programs. That leaves licensed treating physicians as the required point of entry for families looking into the protocol for previously treated metastatic pancreatic ductal adenocarcinoma.
The company describes itself as a clinical-stage precision oncology company that develops novel targeted therapies. It said it discovers and develops cancer treatments through novel combination and monotherapy treatment regimens that enhance clinical benefits.
Previously treated metastatic PDAC
The access protocol is limited to patients with previously treated metastatic pancreatic ductal adenocarcinoma. For affected patients and their doctors, the practical step is straightforward: the treating physician must begin the request process, and the company’s letter allows the protocol to move forward within the FDA framework.
