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  1. FDA Approves Imlunestrant (Inluriyo) for Breast Cancer

    On Sept. 25, 2025, the U.S. Food and Drug Administration (FDA) approved imlunestrant (brand name: Inluriyo) to treat adults diagnosed with estrogen receptor-positive, HER2-negative …

  2. FDA Approves Imlunestrant for ER-Positive, HER2-Negative, ESR1 …

    On September 25, 2025, the U.S. Food and Drug Administration (FDA) approved imlunestrant (Inluriyo ™), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, …

  3. U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, …

    2025年9月25日 · An estimated 50% of patients with ER+, HER2 – metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor In the Phase 3 …

  4. Inluriyo Approved for ER+, HER2-, ESR1-Mutated Metastatic Breast Cancer

    6 天之前 · The FDA has approved Inluriyo for the treatment of adults with previously treated ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.

  5. FDA approves imlunestrant - U.S. Food and Drug Administration

    2025年9月25日 · FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with …

  6. FDA Approves Inluriyo for Advanced Breast Cancer

    6 天之前 · The approval is based on the phase 3 EMBER-3 trial, in which 256 patients with ESR1 -mutated metastatic breast cancer received Inluriyo or ET as first-line treatment following …

  7. FDA Approves Inluriyo - Drugs.com

    2025年9月25日 · All News Consumer Pro New Drugs Pipeline Clinical Trials FDA Alerts FDA Approves Inluriyo FDA Approves Inluriyo (imlunestrant) for Adults with ER+, HER2-, ESR1 …

  8. INLURIYO™ (imlunestrant) FDA-Approved for Treatment of ER+, …

    5 天之前 · This newly FDA-approved oral estrogen receptor antagonist is indicated for the treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic …

  9. Inluriyo: FDA Approves New Once-Daily Pill for ESR1-Mutated Advanced

    2025年9月27日 · The FDA approves Inluriyo (imlunestrant), a new oral treatment for people whose locally advanced or metastatic breast cancer is ER-positive, HER2-negative, and has a …

  10. Lilly’s oral SERD gets FDA nod in advanced breast cancer

    2025年9月25日 · The Food and Drug Administration on Thursday approved a new medicine for breast cancer, clearing Eli Lilly’s Inluriyo for people with a specific genetic mutation. Previously …