Eli Lilly’s New Drug Inluriyo Approved By FDA To Fight Advanced Breast Cancer

Pharmaceutical giant Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) has approved its new oral medicine called Inluriyo (imlunestrant) for the treatment of certain advanced breast cancers.

This new drug is specifically designed for patients with estrogen receptor-positive (ER+), HER2-negative, and ESR1-mutated metastatic breast cancer—a form of cancer that no longer responds well to standard hormone therapies.

It said that Inluriyo works by blocking and breaking down the overactive estrogen receptors that fuel cancer growth in these patients. Clinical trials, particularly the Phase 3 EMBER-3 study, showed that Inluriyo reduced the risk of disease progression or death by 38%, helping patients live longer without their cancer worsening.

According to a statement by the company, Dr. Jacob Van Naarden, President of Lilly Oncology, said, “This approval marks an important milestone, offering patients a new, all-oral treatment option that is effective and easier to take.”

While some mild side effects such as fatigue and nausea were observed, the drug was generally well-tolerated by patients.

Inluriyo is expected to become available in the United States in the coming weeks. Research is ongoing to test its benefits in earlier stages of breast cancer.

ESR1 mutations cause estrogen receptors on cancer cells to become overactive, making some breast cancers resistant to existing hormone therapies. Inluriyo targets these mutations directly, offering new hope for patients, as per the statement.