What's Happening?
Eli Lilly has received FDA approval for its oral selective oestrogen receptor degrader (SERD), imlunestrant, marketed as Inluriyo, for treating advanced breast cancer with ESR1 mutations. Inluriyo is the second oral SERD to be approved, following Menarini/Stemline's Orserdu. The approval is based on the phase 3 EMBER-3 trial, which demonstrated a 38% reduction in disease progression risk compared to existing therapies. Inluriyo targets HR-positive, HER2-negative breast cancer patients whose disease has progressed after endocrine therapy. The drug offers a new treatment option, providing flexibility and hope for patients managing their condition.
Why It's Important?
The approval of Inluriyo represents a significant advancement in breast cancer treatment, particularly for patients with ESR1 mutations who have limited options after first-line therapy. This development highlights the growing importance of targeted therapies in oncology, offering personalized treatment approaches that can improve patient outcomes. Inluriyo's approval provides an additional option for patients, potentially enhancing their quality of life and disease management. The introduction of oral SERDs like Inluriyo could lead to broader applications in earlier treatment settings, further transforming the landscape of breast cancer therapy.
What's Next?
Eli Lilly plans to launch Inluriyo in the coming weeks, priced at $22,500 for a four-week supply. The company is also conducting the EMBER-4 trial to evaluate Inluriyo as an adjuvant therapy for earlier-stage breast cancer. Other companies, including Menarini and AstraZeneca, are exploring similar adjuvant indications for their SERD drugs. The success of these trials could expand the use of oral SERDs in breast cancer treatment, potentially leading to earlier intervention and improved patient outcomes.
