Eli Lilly Wins FDA Approval for Breast Cancer Drug Inluriyo
The new oral therapy targets a specific genetic mutation in advanced or metastatic breast cancer, expanding Lilly's oncology portfolio.
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's (LLY) new oral drug, Inluriyo (imlunestrant), for the treatment of a specific form of advanced or metastatic breast cancer. This approval marks a significant step forward in precision oncology and strengthens Eli Lilly's position in the competitive cancer drug market.
Inluriyo is approved for adults with estrogen receptor-positive (ER+), HER2-negative breast cancer that has an ESR1 mutation. The specify that the drug is for patients whose cancer has progressed after at least one line of endocrine therapy. This targeted approach addresses a key driver of treatment resistance in breast cancer.
The approval was based on the positive results from the EMBER-3 clinical trial, which showed that Inluriyo significantly reduced the risk of disease progression or death compared to standard treatments. In the trial, patients with ESR1 mutations treated with Inluriyo had a median progression-free survival of 5.5 months, compared to 3.8 months for those on standard endocrine therapy. This represents a 38% reduction in the risk of progression or death for this patient population.
Analysts see this approval as a major catalyst for Eli Lilly, positioning the company to capture a significant share of the precision oncology market. Inluriyo is the second oral selective estrogen receptor degrader (SERD) to be approved, following Menarini's Orserdu. However, Inluriyo's approval for patients who have progressed after at least one line of endocrine therapy could give it a broader market than Orserdu, which is limited to second-line treatment. The highlighted the convenience of Inluriyo as a once-daily oral tablet.
The market for this class of drugs is substantial. to reach over $5 billion by 2034, with breast cancer therapies being a major component. Eli Lilly has priced Inluriyo at $22,500 for a four-week supply, which is slightly below the launch price of its main competitor. With a strong efficacy profile and a convenient oral formulation, Inluriyo is expected to be a key growth driver for Eli Lilly's oncology division.
Looking ahead, Eli Lilly is also studying Inluriyo in earlier stages of breast cancer, which could further expand its market potential. The approval of Inluriyo, along with its companion diagnostic to identify patients with ESR1 mutations, underscores the growing importance of personalized medicine in cancer treatment. This latest addition to Eli Lilly's portfolio is a clear indication of the company's commitment to innovation in oncology.