FDA Approves Inluriyo for Advanced Breast Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted approval to Eli Lilly's medication Inluriyo (imlunestrant), an oral drug designed to target and inhibit estrogen receptors in patients with specific types of advanced breast cancer. This approval is significant for adults diagnosed with estrogen receptor-positive, HER2-negative metastatic breast cancer that harbors ESR1 mutations, particularly in cases where the disease has progressed after at least one line of endocrine therapy.

Inluriyo, available in 200 mg tablets, is administered once daily and works by binding to, blocking, and promoting the breakdown of overactive estrogen receptors. This mechanism helps to slow the progression of the disease and offers an alternative for patients with treatment-resistant cancer. The drug's approval was based on findings from the Phase III EMBER-3 clinical trial, where 256 patients with ESR1-mutated metastatic breast cancer received Inluriyo or other endocrine therapies. Results demonstrated that Inluriyo reduced the risk of disease progression or death by 38% compared to standard therapies.

Additionally, Inluriyo significantly extended progression-free survival, with a median of 5.5 months versus 3.8 months for comparators such as fulvestrant or exemestane, achieving a hazard ratio of 0.62. Dr. Komal Jhaveri of Memorial Sloan Kettering Cancer Center, a lead investigator in the trial, highlighted the importance of this development, noting that ESR1 mutations are present in nearly half of hormone therapy-treated metastatic breast cancer cases and often lead to resistance against conventional treatments.

The introduction of Inluriyo offers a promising new option for patients facing this challenging diagnosis, combining demonstrated efficacy, a tolerable safety profile, and the convenience of oral administration. More details can be found in the official announcement from Eli Lilly and additional information about the trial results on the Lilly investor page.