FDA Approves Guardant360® CDx as Companion Diagnostic for Eli Lilly and Company’s Inluriyo™ (imlunestrant) for Treatment of ESR1-mutated Advanced Breast Cancer

Original from: Guardant Health

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company’s Inluriyo (imlunestrant). Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy (ET).

“This FDA approval provides another treatment for breast cancer patients with ESR1 mutations for their specific type of cancer along with expanded access to comprehensive genomic profiling with a simple blood draw,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Precision testing plays a critical role in helping physicians identify the correct treatment, providing patients and their doctors with the comprehensive genomic profiling needed to see if they are eligible to receive the right treatment and improving outcomes.”

Breast cancer remains the second leading cause of cancer death among women in the United States. Guardant360 CDx was used to identify patients who had ESR1 mutations in the Phase 3 EMBER-3 trial, in which Inluriyo was found to reduce the risk of progression or death by 38% versus ET. Patients with ESR1 E380, V422del, S463, L469, L536, Y537, and D538 mutations detected by Guardant360 CDx are eligible for treatment with Inluriyo.

The Inluriyo approval as a companion diagnostic marks the sixth CDx claim approved by the FDA for Guardant360 CDx, and the second FDA-approved indication in breast cancer treatment, following a similar approval for ORSERDU™ (elacestrant) granted by the FDA in 2023.

Source: FDA Approves Guardant360® CDx as Companion Diagnostic for Eli Lilly and Company’s Inluriyo™ (imlunestrant) for Treatment of ESR1-mutated Advanced Breast Cancer