Onco-Summaries: Daily Oncology Updates at a Glance

25/09/2025

Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer (Ref)

The US FDA approved Eli Lilly and Company's Inluriyo (imlunestrant, oral estrogen receptor antagonist) for the treatment of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

• The FDA approval is based on the results of the Phase 3 EMBER-3 trial

  
  

  • Inluriyo reduced the risk of progression or death by 38% vs ET

    
    

  • median PFS: 5.5 months vs 3.8 months (HR=0.62; p-value=0.0008)

Biostar Pharma's Utidelone received the FDA ODD for pancreatic cancer (Ref)

The US FDA granted the orphan drug designation to Biostar Pharma's Utidelone (microtubule inhibitor) for the treatment of pancreatic cancer. 

• This is the third ODD granted to the asset, following prior designations for breast cancer brain metastases and gastric cancer.