Case Study: Loxo@Lilly expands Retevmo label in thyroid cancer with Genomenon

Loxo@Lilly secures thyroid cancer label expansion in weeks with Genomenon

Loxo@Lilly faced a significant challenge when seeking to expand the regulatory label for Retevmo® in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) required comprehensive, reference-backed evidence for every RET mutation detected by their companion diagnostic, a task that was impossible to complete within the required weeks using traditional internal curation methods. To overcome this hurdle, Loxo@Lilly partnered with vendor Genomenon and its Mastermind genomic database service.

Genomenon implemented an AI-powered, human-validated solution that rapidly scanned millions of scientific articles to curate evidence for 97 RET mutations. This provided the real-world evidence needed to demonstrate clinical actionability and patient benefit. The solution enabled Loxo@Lilly to secure co-approval for Retevmo® in Japan with an expanded label, compressing an evidence generation process that would normally take months into just a few weeks.

Loxo@Lilly