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The FDA has allowed Revolution Medicines to give patients early access to the company’s investigational RAS(ON) inhibitor daraxonrasib for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
FDA regulations allow early access to investigational drugs for serious or life-threatening conditions outside of a clinical trial and before approval under an expanded access treatment protocol (EAP) when no comparable or satisfactory alternatives are available.
Per EAP guidelines, requests for daraxonrasib must be submitted to Revolution Medicines by a licensed treating physician on behalf of an eligible patient.
“The EAP is intended to provide treatment access in a controlled and monitored setting, consistent with FDA regulations governing investigational medicines,” Revolution said in a press release, noting that it is “moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients.”
Daraxonrasib is a once-daily pill designed to inhibit mutated RAS protein found in most pancreatic tumors.
Revolution’s request for an EAP came shortly after the company reported what it called “ unprecedented” results from the phase 3 RASolute 302 trial.
In patients with previously treated, metastatic PDAC, overall survival was 13.2 months with daraxonrasib vs 6.7 months with investigators choice of chemotherapy.
The company plans to submit an approval application to FDA based on the results. It’s already received a priority review voucher from the agency.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@medscape.net
