Case Study: Loxo@Lilly expands Retevmo’s label with Genomenon

Loxo@Lilly expands Retevmo label by 15% with Genomenon

The customer, Loxo@Lilly, faced the challenge of securing regulatory approval for its precision oncology drug Retevmo, as incomplete classification of RET variants would limit the drug's label and patient access. They partnered with the vendor Genomenon to build a comprehensive evidence package required by regulators.

Genomenon applied its AI-powered search and expert curation across scientific literature to build a detailed variant evidence package for the submission. This solution resulted in PMDA approval for Retevmo with 73 additional variants included in the label and an 8-variant removal based on counter-evidence, leading to a 4.1x increase in eligible variants and access for 15% more medullary thyroid cancer patients.

Loxo@Lilly