US EditionFDA Approves Eli Lilly's Drug For Advanced Breast Cancer - Eli Lilly (NYSE:LLY)
Imlunestrant reduces progression or death risk by 38% in ESR1-mutated metastatic breast cancer after endocrine therapy failure, based on EMBER-3 trial results.
- The FDA authorized Eli Lilly's oral medication Inluriyo on Thursday for adults with hormone receptor-positive, HER2-negative breast cancer that has spread and carries ESR1 genetic mutations.
- The approval followed results from the EMBER-3 trial showing Inluriyo reduced disease progression or death risk by 38% versus standard endocrine therapies in ESR1-mutated patients.
- Inluriyo delivers a median progression-free survival of 5.5 months compared to 3.8 months with endocrine therapy and joins Menarini's Orserdu as FDA-approved oral SERDs for this mutation.
- Jacob Van Naarden called the approval an important step toward innovative all-oral treatments, while Komal Jhaveri highlighted it as a meaningful option for patients with treatment-resistant ESR1-mutated disease.
- The therapy offers a new oral treatment with manageable side effects, but its full impact on breast cancer care remains to be seen as ongoing studies explore use in early breast cancer.
13 Articles
13 Articles
FDA Approves New Therapy for Advanced Breast Cancer
The Food and Drug Administration on Sept. 25 approved a new therapy for advanced breast cancer, based on data from a phase 3 clinical trial. Regulators said in a statement that they approved imlunestrant, also known as Inluriyo, from Eli Lilly. The therapy, an estrogen receptor antagonist, is cleared for adults who have advanced or metastatic breast cancer with estrogen receptor-1 mutations. Metastatic breast cancer, also called Stage IV breast …
FDA Approves Eli Lilly's Drug For Advanced Breast Cancer - Eli Lilly (NYSE:LLY)
On Thursday, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Co.’s (NYSE: LLY) Inluriyo (imlunestrant) for adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). The FDA approval is based on the results of the EMBER-3 trial in the patient populatio…
MedPage Today
Anti-Aging, Acupuncture and Health NewsOral Breast Cancer Drug Wins Broader FDA Nod for ESR1-Mutated Disease
(MedPage Today) -- The FDA approved the oral estrogen receptor antagonist imlunestrant (Inluriyo) for previously treated ESR1-mutated advanced/metastatic breast cancer, the agency announced Thursday. The approval stipulates use in adults with...
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