Programs

Policy and Protocols for Access to Investigational Agents


Loxo@Lilly 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@Lilly investigational drug that is in active clinical development must submit the Loxo@Lilly Expanded Access Program request form to clinicaltrials@loxooncology.com. Treating physicians should take care not to include identifying personal health information (PHI).

Loxo@Lilly 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@Lilly will review the request in the context of its Policy for Evaluating Access to Investigational Agents Outside of Loxo@Lilly Clinical Trials. Loxo@Lilly will attempt to make a decision to grant or deny the request, or ask for more information, within 10 business days.

Questions about Loxo@Lilly’s policy and procedures for expanded access, or about expanded access to Loxo@Lilly investigational drugs, should be sent by email to: clinicaltrials@loxooncology.com.