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2mo ago

FDA Approves Lilly’s Inluriyo for ESR1‑Mutated Advanced Breast Cancer

The once-daily oral therapy cut the risk of progression or death by 38% in the phase 3 EMBER‑3 trial.

FDA Approves Eli Lilly’s Inluriyo For Advanced Breast Cancer, Here's All You Need To Know About Oral SERD
Breakthrough Breast Cancer Drug Approved, Progression Risk Falls 40 percent

Overview

  • The authorization covers adults with ER+, HER2–, ESR1‑mutated advanced or metastatic disease after at least one course of endocrine therapy.
  • In ESR1‑mutated patients, median progression‑free survival reached 5.5 months with Inluriyo versus 3.8 months with fulvestrant or exemestane.
  • Inluriyo binds to, blocks, and promotes degradation of estrogen receptors that can become overactive due to ESR1 mutations.
  • The label includes a fetal‑risk warning and notes mostly low‑grade adverse events such as fatigue, musculoskeletal pain, gastrointestinal symptoms, and elevated cholesterol and triglycerides.
  • Lilly says U.S. availability is expected in the coming weeks, and the medicine is being evaluated further in the phase 3 EMBER‑4 trial that plans to enroll about 8,000 patients globally.