FDA Approves Eli Lilly's Oral SERD Inluriyo for Advanced Breast Cancer
Eli Lilly has secured FDA approval for Inluriyo (imlunestrant), marking a significant advancement in the treatment of advanced breast cancer. The oral selective estrogen receptor degrader (SERD) is now cleared for use in adult patients with ER-positive, HER2-negative advanced or metastatic breast cancer who carry ESR1 mutations and have progressed after at least one line of endocrine therapy.
Inluriyo's Efficacy and Market Position
The approval is based on results from the Phase III EMBER-3 study, which demonstrated that Inluriyo reduced the risk of disease progression or death by 38% compared to standard endocrine therapy in patients with ESR1 mutations. The drug delayed tumor progression by a median of 5.5 months, approximately two months longer than typical treatments.
Inluriyo joins Menarini Group's Orserdu as the second FDA-approved oral SERD, positioning itself in a growing market for alternatives to AstraZeneca's injectable SERD, Faslodex. With a list price of $22,500 for a 28-day supply, Inluriyo enters a competitive landscape that includes upcoming candidates from Roche, AstraZeneca, and a partnership between Arvinas and Pfizer.
Clinical Profile and Patient Impact
The majority of side effects associated with Inluriyo were reported as low grade, including decreased hemoglobin and white blood cell counts, pain, fatigue, and diarrhea. The FDA's prescribing information includes a warning for potential harmful effects on developing fetuses.
Dr. Komal Jhaveri, Clinical Director of Early Drug Development at Memorial Sloan Kettering Cancer Center, highlighted the significance of this approval, stating, "This represents an important advancement for patients with ESR1-mutated metastatic breast cancer, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance."
Future Developments and Market Outlook
Lilly is exploring Inluriyo's potential in early breast cancer as an adjuvant therapy, with initial results expected in 2027. This could significantly expand the drug's market potential. Meanwhile, competitors are advancing their own oral SERDs, with Roche recently announcing positive Phase III results for giredestrant in combination with everolimus.
The development of oral SERDs represents a broader trend in the pharmaceutical industry towards more convenient and targeted therapies for breast cancer patients. As the market evolves, the impact of these new treatments on cancer care and their potential to supplant existing therapies remains a subject of ongoing evaluation among oncologists and industry analysts.
References
- Lilly’s Oral SERD Wins FDA Go-Ahead for Breast Cancer
Phase III data showed that Inluriyo improves progression-free survival versus standard endocrine therapy.
- Lilly’s oral SERD gets FDA nod in advanced breast cancer
The clearance of Inluriyo is another development among a group of oral medicines aiming to supplant a widely used, injectable type of hormone therapy.
- Eli Lilly's oral SERD Inluriyo passes muster with FDA in breast cancer
Eli Lilly has won the second FDA approval for an oral selective estrogen receptor degrader (SERD), albeit in a confined breast cancer indication like Menarini's drug before it.
Explore Further
What additional details are available about the Phase III EMBER-3 study that led to the FDA approval of Inluriyo?
How does Inluriyo's pricing strategy compare to its main competitors, such as Orserdu and Faslodex?
What is the projected market size for oral SERDs in the treatment of ER-positive, HER2-negative advanced or metastatic breast cancer?
What specific safety concerns or adverse events were observed during clinical trials of Inluriyo, and how do these compare to similar drugs in the market?
What are the latest developments in Roche, AstraZeneca, and Arvinas/Pfizer's oral SERD candidates, and how do their clinical results compare to Inluriyo’s?