FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
The FDA issued a 'safe to proceed' letter to Revolution Medicines, permitting the initiation of an expanded access treatment protocol (EAP) for the investigational pancreatic cancer drug daraxonrasib.
Revolution Medicines, clinical trial sponsors developing oncology therapeutics, and regulatory affairs and clinical operations professionals.
The authorization suggests that the FDA has determined the proposed protocol meets the criteria for expanded access, allowing patients with serious or life-threatening conditions to gain access to an investigational drug outside of traditional clinical trials. For the sponsor, this necessitates rigorous management of drug supply, safety reporting, and data collection under a specific treatment protocol that differs from standard clinical trial workflows.
Clinical and regulatory teams should prepare for the unique reporting requirements and supply chain logistics associated with an EAP. Ensure that pharmacovigilance systems are equipped to capture and process safety data from patients treated outside of the primary clinical trial setting.
FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.
Open in openFDA / FDA.gov