Case Study: Loxo@Lilly advances RET companion diagnostic approval in Japan with Genomenon

Loxo@Lilly adds 73 RET variants with Genomenon

Loxo@Lilly faced the challenge of securing co-approval in Japan for its precision cancer therapy, selpercatinib, and its companion diagnostic. The Japanese regulatory agency, PMDA, required meticulous evidence for each genetic variant the diagnostic would claim to detect, a complex and time-consuming process. To address this, Loxo@Lilly partnered with the vendor Genomenon and its AI-powered genomic knowledgebase.

Genomenon provided a comprehensive, expert-curated analysis of approximately 97 RET gene variants, categorizing them by pathogenicity according to established clinical guidelines. This evidence enabled Loxo@Lilly to definitively justify which variants to include in or exclude from the diagnostic's claim, directly addressing PMDA's rigorous requirements. The use of Genomenon's service was critical for the timely and successful co-approval of both the drug and its companion diagnostic in Japan.

Loxo@Lilly