Policy and Protocols for Access to Investigational Agents
Loxo Oncology is committed to helping patients who have not responded to available therapies and may benefit from its investigational therapies. Loxo Oncology’s Policy for Access to Investigational Agents describes the principles that the company will follow when considering a request, view here.
Procedure for Requesting Expanded Access and Response Times
Treating physicians interested in treating a patient with a Loxo Oncology investigational drug that is in active clinical development must submit the Loxo Oncology Expanded Access Program request form to email@example.com. Treating physicians should take care not to include identifying personal health information (PHI).
Loxo Oncology will acknowledge a satisfactorily completed and submitted request via email within 5 business days.
Making a request does not guarantee the granting of access to an investigational drug. Loxo Oncology will review the request in the context of its Policy for Evaluating Access to Investigational Agents Outside of Loxo Oncology Clinical Trials. Loxo Oncology will attempt to make a decision to grant or deny the request, or ask for more information, within 10 business days.
Questions about Loxo Oncology’s policy and procedures for expanded access, or about expanded access to Loxo Oncology investigational drugs, should be sent by email to: firstname.lastname@example.org.