What is the story about?
What's Happening?
Eli Lilly's imlunestrant, marketed as Inluriyo, has received FDA approval as a second-line treatment for ER-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutations. The approval is based on the Phase III EMBER-3 study, which showed a 38% improvement in progression-free survival compared to standard endocrine therapy. Inluriyo is taken orally, offering a more convenient alternative to injectable SERDs. The drug is expected to be available in the coming weeks, with a 28-day supply priced at $22,500.
Why It's Important?
The approval of Inluriyo marks a significant development in the treatment of advanced breast cancer, particularly for patients with ESR1 mutations who have exhausted other endocrine therapies. The oral administration of Inluriyo provides a more patient-friendly option, potentially improving adherence and outcomes. This approval could pave the way for further research and development of oral SERDs, potentially expanding their use in breast cancer treatment and offering new hope to patients with limited options.
What's Next?
Eli Lilly plans to continue evaluating Inluriyo's efficacy in ongoing trials, including its potential use in combination with other therapies. The company is also exploring the drug's application in earlier stages of breast cancer, which could broaden its use and impact in oncology. As Inluriyo enters the market, it may influence treatment guidelines and encourage further innovation in breast cancer therapies.
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