On September 29, 2025 the U.S. Food and Drug Administration approved Guardant360® CDx as a companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant). Inluriyo is an oral estrogen‑receptor antagonist indicated for estrogen‑receptor‑positive, HER2‑negative, ESR1‑mutated advanced breast cancer.
The approval expands Lilly’s oncology portfolio by providing a companion diagnostic that identifies patients with ESR1 mutations who are most likely to benefit from Inluriyo. This targeted approach can improve treatment efficacy and patient outcomes while increasing the drug’s market size.
The regulatory milestone is expected to boost Inluriyo sales, enhance Lilly’s position in the breast‑cancer market, and support the company’s broader strategy of securing companion diagnostics for its oncology assets.
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