Eli Lilly's Inluriyo Secures FDA Approval for Advanced Breast Cancer Treatment

Eli Lilly has achieved a significant milestone in the pharmaceutical industry with the U.S. Food and Drug Administration's (FDA) approval of Inluriyo (imlunestrant) for the treatment of advanced breast cancer. This development marks a crucial advancement in oral selective estrogen receptor degrader (SERD) therapies and offers new hope for patients with specific genetic mutations.

FDA Approval and Indications

The FDA has cleared Inluriyo for use in adults with metastatic, estrogen receptor-positive (ER-positive), HER2-negative breast cancer that has progressed after at least one line of hormone therapy. Specifically, the drug is indicated for patients with mutations in the ESR1 gene, which Lilly estimates occur in approximately half of the patients with this form of breast cancer during or after exposure to hormone therapy.

Dr. Komal Jhaveri, clinical director of early drug development at Memorial Sloan Kettering Cancer Center and a principal investigator in the pivotal trial, emphasized the significance of this approval, stating, "This represents an important advancement for patients with ESR1-mutated [metastatic breast cancer], a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance."

Clinical Trial Results and Efficacy

The FDA's decision was based on results from the phase 3 EMBER-3 trial, published in the New England Journal of Medicine. The study demonstrated that Inluriyo reduced the risk of disease progression or death by 38% compared to standard hormone-suppressing therapies in patients with ESR1 mutations. Median tumor progression was delayed by 5.5 months with Inluriyo, approximately 2 months longer than with typical drugs.

Jacob Van Naarden, executive vice president and head of Lilly's oncology division, noted that this approval represents an "important step toward advancing innovative, all-oral treatment approaches" in breast cancer care.

Safety Profile and Pricing

The majority of side effects associated with Inluriyo were reported as "low grade," including decreased hemoglobin and white blood cell counts, pain, fatigue, and diarrhea. Adverse events led to treatment discontinuation in 4.6% of patients, while 10% experienced treatment interruptions due to side effects. The FDA's prescribing information includes a warning about potential harmful effects on developing fetuses.

Lilly has set the list price for a 28-day supply of Inluriyo at $22,500 per patient.