Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer


Shots:

  • FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks.
  • Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane in ESR1-mutated breast cancer pts (n=256); Inluriyomonotx. showed improved PFS by 38% (mPFS: 5.5 vs 3.8mos.)
  • Inluriyo is also being studied in P-III (EMBER-4) trial (with abemaciclib) as an adj. therapy for early breast cancer & P-I (EMBER) trial for advanced or metastatic breast cancer or endometrial cancer

Ref: Eli Lilly | Image: Eli Lilly| Press Release

Related News:- Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

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