Programs

Selpercatinib


LOXO-292 is an oral and selective investigational drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC).

Both RET fusion cancers and RET-mutant MTC are primarily dependent on a single activated kinase for their proliferation and survival. This dependency, often referred to as “oncogene addiction,” renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial.

For more information about the LOXO-292 clinical trial, please refer to clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email  clinicaltrials@loxooncology.com.


LOXO-292 Phase 1/2 Trial

LOXO-292 is currently being evaluated in a global, multi-center Phase 1/2 trial in patients with advanced solid tumors.

For more information about the LOXO-292 clinical trial, please refer to  clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email clinicaltrials@loxooncology.com.

Policy 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 

  1. 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 clinicaltrials@loxooncology.com. Treating physicians should take care not to include identifying personal health information (PHI). 
  2. Loxo Oncology will acknowledge a satisfactorily completed and submitted request via email within 5 business days.   
  3. 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: clinicaltrials@loxooncology.com.